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A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

Primary Purpose

Cystitis, Interstitial

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tanezumab
Tanezumab
Tanezumab
Tanezumab
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial focused on measuring Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
  • Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

  • Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
  • Body mass index (BMI) of >39 kg/m2.
  • History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  • Patients with peripheral neuropathy.
  • Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.

Sites / Locations

  • Alabama Orthopaedic Clinic
  • Coastal Clinical Research, Inc.
  • Canyon State Urology
  • Elite Clinical Studies, LLC
  • Urology Specialists, Ltd.
  • Central Arizona Urologists
  • Arizona Research Center
  • Precision Trials, LLC
  • Valley Radiologists (x-ray only)
  • Valley Urologic Associates
  • Scottsdale Medical Imaging
  • Radiology Limited (x-ray only)
  • Arizona Urologic Specialists
  • Access Medical Imaging
  • Urology Associates of Central California
  • Citrus Valley Medical Research Inc.
  • Atlantic Urology Medical Group
  • Institute for Advanced Urology
  • Tri Valley Urology Group
  • Valley Neurology
  • Liberty Pacific Medical Imaging
  • Boulder Medical Center, PC
  • Longmont Clinic, PC
  • Longmont Medical Research Network
  • Women's Health Specialty Care
  • Grove Hill Clinical Research
  • Urology Center of Grove Hill
  • Brian J. Hines, MD
  • Stamford Therapeutics Consortium
  • Diagnostic Imaging (radiology only)
  • Urology Associates of Dover
  • Visions Clinical Research
  • Jacksonville Center for Clinical Research
  • University Urologists
  • Specialists in Urology
  • Advanced Urology Associates
  • Excel Medical Imaging
  • Urology Specialists of West Florida
  • Advanced Imaging Center Incorporated
  • Ocala Urology Specialists
  • Renstar Medical Research
  • Gateway Radiology (x-rays only)
  • Pinellas Urology, Inc.
  • Advanced Research Institute Incorporated
  • Midtown Imaging
  • Atlanta Medical Research Institute, LLC
  • Northside Hospital Radiology Services (x-ray only)
  • Atlanta Center for Medical Research
  • MRI Imaging of Georgia
  • MRI Imaging Of Georgia
  • Georgia Urology
  • Deaconess Clinic Downtown Research Institute
  • Metropolitan Urology
  • Deaconess Clinic Gateway Health Center Research Institute
  • American Health Network (X-Ray only)
  • Urology of Indiana, LLC
  • The Iowa Clinic, Medical Imaging
  • The Iowa Clinic, Urology
  • Regional Urology, LLC
  • Anne Arundel Diagnostics Imaging
  • Anne Arundel Urology, PA
  • Alpha Clinical Research
  • Genesis Clinical Research and Consulting
  • Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan
  • HealthCare Midwest
  • Rheumatology PC
  • Beyer Research
  • Beaumont Hospitals - Royal Oak
  • Michigan Institute of Urology, P.C.
  • CRL Imaging Southdale (x-rays only)
  • Medical Advanced Pain Specialists Applied Research Center Incorporated
  • Southeast Urology Network
  • Family Health Care Center (X-Ray)
  • Women's Clinic of Lincoln, P.C.
  • Capital Region Urological Surgeons
  • Benedictine Hospital
  • Hudson Valley Urology, PC
  • University Urology Associates
  • DRA Imaging, PC (X-Rays Only)
  • Hudson Valley Urology, PC
  • University of Rochester Medical Center
  • University of Rochester, Department of Urology
  • Crescent Medical Research
  • Salisbury Urological Clinic
  • Piedmont Medical Research
  • Tri-State Urologic Services PSC, Inc. dba The Urology Group
  • Central Ohio Urology Group
  • Columbus Urology Research, LLC
  • Premier Urology
  • Legacy Clinical Research, LLC
  • Planned Parenthood of Arkansas and Eastern Oklahoma
  • Oklahoma State University
  • Institute for Female Pelvic Medicine and Reconstructive Surgery
  • Urologic Consultants of Southeastern Pennsylvania
  • Jeanes Hospital
  • Matrix Research, LLC
  • The Urology Group
  • Bristol Urological Associates, PC
  • TriCities Medical Research
  • New Orleans Center for Clinical Research
  • University Urology
  • Volunteer Research Group
  • The Neurology Clinic
  • Southeast Urology Network
  • The West Clinic
  • Access Clinical Trials, Inc (ACT)
  • Center for Urological Treatment
  • Diagnostic Health
  • Swan and Brennan, Incorporated
  • The Center for Reproductive Health
  • Mobley Research Center
  • Advances In Health, Inc.
  • St. Luke's Diagnostic and Treatment Center Kirby Glen
  • Centex Research, Inc.
  • Rocky Mountain Neurological Associates
  • Salt Lake Surgical Center
  • Salt Lake Regional Medical Center (X-rays only)
  • Salt Lake Research, PLLC
  • Western Urological Clinic, PC
  • Integrity Medical Research, LLC
  • Urology Northwest
  • Marc Kirschner, MD
  • Universitair Ziekenhuis Brussel
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Universitair Ziekenhuis Gasthuisberg
  • The Gateway 2
  • The Male/Female Health and Research Centre, Royal Court Medical Centre
  • Centre for Applied Urological Research
  • Kingston General Hospital
  • Urology Associates / Urologic Medical Research
  • Anthony Skehan Medicine Professional Corporation
  • Sunnybrook Health Sciences Centre
  • Centre Hospitalier Universitaire de Sherbrooke
  • Kouvolan Laakariasema
  • Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong
  • Department of Surgery, The Chinese University of Hong Kong
  • Harasanshin Hospital, Urology
  • Kyoto City Hospital, Urology
  • Tokyo Women's Medical University Medical Center East
  • Tokyo University Hospital
  • Department of Urology, Asan Medical Center, University of Ulsan
  • Department of Urology, Seoul National University Hospital
  • Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
  • Department of Urology, Korea University Anam Hospital
  • SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii
  • Conti Medica Sp. z o.o.
  • Spoldzielnia Pracy Specjalistow Radiologow
  • NZOZ Centrum Medyczne Wola
  • Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen
  • Dinu Uromedica SCM
  • Spitalul Clinic Prof. Dr. Th. Burghele
  • Centrul Medical Sf. Pantelimon
  • Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology
  • Urology of Rosmedtechnology
  • Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology
  • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava
  • SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology
  • Martinska fakultna nemocnica
  • Univerzitna nemocnica Martin
  • MILAB s.r.o.
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Clinica Del Remei - Instituto Medico Tecnologico
  • Hospital Clinic I Provincial de Barcelona
  • Kliniska provningsenheten
  • Medicinsk Rontgen (x-ray only)
  • Center for Lakemedelsprovning Malmo
  • Chang Gung Medical Foundation - Kaohsiung/Department of Surgery
  • Taichung Hospital, Department of Health, Executive Yuan
  • Taipei Veterans General Hospital (X-Ray Only)
  • Taipei Veterans General Hospital/Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Average Daily Pain Score at Week 8
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

Secondary Outcome Measures

Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Patient Global Assessment of Health Status Scores
Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.
Number of Participants With Global Response Assessment Scores
Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.
Number of Micturitions Per 24 Hours
The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.
Number of Nocturnal Micturitions Per 24 Hours
The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Number of Micturition-related Urgency Episodes Per 24 Hours
The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Participant's Urge to Urinate
Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.
Mean Voided Volume Per Micturition
Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.
Brief Pain Inventory-Short Form (BPI-sf) Score
BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.
Number of Participants With Patient Global Satisfaction Assessment Scores
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.
Number of Participants With Patient Global Preference Assessment Score
Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.
Number of Participants With Willingness to Re-use Medicine Assessment
Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.
Percentage of Participants Who Received Rescue Medication
For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Number of Days of Rescue Medication Usage Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Number of Rescue Medication Doses Used Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Amount of Rescue Medication Taken Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.
Serum Total Nerve Growth Factor (NGF) Levels
Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.

Full Information

First Posted
October 20, 2009
Last Updated
July 12, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00999518
Brief Title
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Official Title
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
January 22, 2010 (Actual)
Primary Completion Date
November 17, 2010 (Actual)
Study Completion Date
January 21, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels
Detailed Description
This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Arm Title
Group 4
Arm Type
Experimental
Arm Title
Group 5
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Tanezumab
Intervention Description
1 mg dose given subcutaneously twice at an 8-week interval.
Intervention Type
Biological
Intervention Name(s)
Tanezumab
Intervention Description
2.5 mg dose given subcutaneously twice at an 8-week interval.
Intervention Type
Biological
Intervention Name(s)
Tanezumab
Intervention Description
10 mg dose given subcutaneously twice at an 8-week interval.
Intervention Type
Biological
Intervention Name(s)
Tanezumab
Intervention Description
20 mg dose given subcutaneously twice at an 8-week interval.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo dose given subcutaneously twice at an 8-week interval.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Average Daily Pain Score at Week 8
Description
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Description
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Description
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time Frame
Week 8, 16
Title
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Description
Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Patient Global Assessment of Health Status Scores
Description
Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.
Time Frame
Baseline, Week 2, 8, 16, 24
Title
Number of Participants With Global Response Assessment Scores
Description
Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.
Time Frame
Week 8, 16, 24
Title
Number of Micturitions Per 24 Hours
Description
The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Number of Nocturnal Micturitions Per 24 Hours
Description
The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Number of Micturition-related Urgency Episodes Per 24 Hours
Description
The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Participant's Urge to Urinate
Description
Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Mean Voided Volume Per Micturition
Description
Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Description
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.
Time Frame
Baseline, Week 2, 8, 16, 24
Title
Brief Pain Inventory-Short Form (BPI-sf) Score
Description
BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.
Time Frame
Baseline, Week 8, 16, 24
Title
Number of Participants With Patient Global Satisfaction Assessment Scores
Description
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.
Time Frame
Week 8, 16, 24
Title
Number of Participants With Patient Global Preference Assessment Score
Description
Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.
Time Frame
Week 8, 16, 24
Title
Number of Participants With Willingness to Re-use Medicine Assessment
Description
Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).
Time Frame
Week 8, 16, 24
Title
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
Description
EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Baseline, Week 8, 16, 24
Title
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
Description
PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.
Time Frame
Baseline, Week 2, 8, 16, 24
Title
Percentage of Participants Who Received Rescue Medication
Description
For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Number of Days of Rescue Medication Usage Per Week
Description
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Number of Rescue Medication Doses Used Per Week
Description
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Amount of Rescue Medication Taken Per Week
Description
In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Title
Serum Total Nerve Growth Factor (NGF) Levels
Description
Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.
Time Frame
Baseline, Week 1, 2, 8, 16, 24
Other Pre-specified Outcome Measures:
Title
Number of Participants With Neurological Examination Findings
Description
A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.
Time Frame
Week 2, 8, 16, Week 24 or early termination
Title
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Description
The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.
Time Frame
Baseline, Week 2, 8, 16, 24
Title
Body Temperature
Time Frame
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Title
Systolic and Diastolic Blood Pressure
Description
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
Time Frame
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Title
Heart Rate
Time Frame
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Title
Respiratory Rate
Time Frame
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Title
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Description
Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).
Time Frame
Screening, Day 1, Week 2, 8, 16, 24
Title
Electrocardiogram Parameter: Heart Rate
Time Frame
Screening, Day 1, Week 2, 8, 16, 24
Title
Post-void Residual (PVR) Volume
Description
PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.
Time Frame
Screening, Week 2, 8, 16, 24
Title
Number of Participants With Urinalysis Abnormalities
Description
Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (<1.003 and >1.030), urine pH (<4.5 and >8), protein (>=1 value in qualitative test), glucose (>=1 value in qualitative test), ketones (>=1 value in qualitative test), blood (>=1 value in qualitative test), bilirubin (>=1 value in qualitative test), nitrites (>=1), and leukocyte esterase (>=1) are reported.
Time Frame
Screening up to Week 24
Title
Number of Participants With Laboratory Test Abnormalities
Description
Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.
Time Frame
Screening up to Week 24
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time Frame
Baseline up to 112 days after the last dose (up to Week 24)
Title
Number of Participants With Anti-Drug Antibody (ADA)
Description
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.
Time Frame
Baseline, Week 8, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day. Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped. Exclusion Criteria: Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome. Body mass index (BMI) of >39 kg/m2. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein. Patients with peripheral neuropathy. Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Orthopaedic Clinic
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Canyon State Urology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Urology Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Central Arizona Urologists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Precision Trials, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valley Radiologists (x-ray only)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Valley Urologic Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Scottsdale Medical Imaging
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Radiology Limited (x-ray only)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Access Medical Imaging
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Urology Associates of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Citrus Valley Medical Research Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Atlantic Urology Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Institute for Advanced Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Tri Valley Urology Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Valley Neurology
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Liberty Pacific Medical Imaging
City
Signal Hill
State/Province
California
ZIP/Postal Code
90755
Country
United States
Facility Name
Boulder Medical Center, PC
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Longmont Clinic, PC
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Grove Hill Clinical Research
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Urology Center of Grove Hill
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Brian J. Hines, MD
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Diagnostic Imaging (radiology only)
City
Dover
State/Province
Delaware
ZIP/Postal Code
19901
Country
United States
Facility Name
Urology Associates of Dover
City
Dover
State/Province
Delaware
ZIP/Postal Code
19904
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University Urologists
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Urology Associates
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Excel Medical Imaging
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Urology Specialists of West Florida
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Advanced Imaging Center Incorporated
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Ocala Urology Specialists
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Gateway Radiology (x-rays only)
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Pinellas Urology, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Advanced Research Institute Incorporated
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Midtown Imaging
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33417
Country
United States
Facility Name
Atlanta Medical Research Institute, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Northside Hospital Radiology Services (x-ray only)
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
MRI Imaging of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
MRI Imaging Of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Georgia Urology
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Deaconess Clinic Downtown Research Institute
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Deaconess Clinic Gateway Health Center Research Institute
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
American Health Network (X-Ray only)
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Urology of Indiana, LLC
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
The Iowa Clinic, Medical Imaging
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
The Iowa Clinic, Urology
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Anne Arundel Diagnostics Imaging
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Anne Arundel Urology, PA
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Alpha Clinical Research
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Genesis Clinical Research and Consulting
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
HealthCare Midwest
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Rheumatology PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009-2175
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Beaumont Hospitals - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Michigan Institute of Urology, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
CRL Imaging Southdale (x-rays only)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Medical Advanced Pain Specialists Applied Research Center Incorporated
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Southeast Urology Network
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Family Health Care Center (X-Ray)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Women's Clinic of Lincoln, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Capital Region Urological Surgeons
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Benedictine Hospital
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
DRA Imaging, PC (X-Rays Only)
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester, Department of Urology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Salisbury Urological Clinic
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Tri-State Urologic Services PSC, Inc. dba The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Central Ohio Urology Group
City
Cofumbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Columbus Urology Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
Premier Urology
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Legacy Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Planned Parenthood of Arkansas and Eastern Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
Facility Name
Oklahoma State University
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Institute for Female Pelvic Medicine and Reconstructive Surgery
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Jeanes Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Matrix Research, LLC
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
The Urology Group
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Bristol Urological Associates, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University Urology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
The Neurology Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Southeast Urology Network
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Access Clinical Trials, Inc (ACT)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Center for Urological Treatment
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Diagnostic Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Swan and Brennan, Incorporated
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Center for Reproductive Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Mobley Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Advances In Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Diagnostic and Treatment Center Kirby Glen
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Centex Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Rocky Mountain Neurological Associates
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Salt Lake Surgical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Salt Lake Regional Medical Center (X-rays only)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Salt Lake Research, PLLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Western Urological Clinic, PC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Urology Northwest
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Marc Kirschner, MD
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
The Gateway 2
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 3N5
Country
Canada
Facility Name
The Male/Female Health and Research Centre, Royal Court Medical Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Centre for Applied Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7N 2V7
Country
Canada
Facility Name
Urology Associates / Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Anthony Skehan Medicine Professional Corporation
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 6E7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Kouvolan Laakariasema
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong
City
Shatin
State/Province
NEW Territories
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Department of Surgery, The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Facility Name
Harasanshin Hospital, Urology
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Facility Name
Kyoto City Hospital, Urology
City
Nakagyo-ku, Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
604-8845
Country
Japan
Facility Name
Tokyo Women's Medical University Medical Center East
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-8567
Country
Japan
Facility Name
Tokyo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Department of Urology, Asan Medical Center, University of Ulsan
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Department of Urology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Department of Urology, Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii
City
Bialystok
ZIP/Postal Code
15-950
Country
Poland
Facility Name
Conti Medica Sp. z o.o.
City
Warszawa
ZIP/Postal Code
00-846
Country
Poland
Facility Name
Spoldzielnia Pracy Specjalistow Radiologow
City
Warszawa
ZIP/Postal Code
01-194
Country
Poland
Facility Name
NZOZ Centrum Medyczne Wola
City
Warszawa
ZIP/Postal Code
01-432
Country
Poland
Facility Name
Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Dinu Uromedica SCM
City
Bucuresti
State/Province
Sector 4
ZIP/Postal Code
041345
Country
Romania
Facility Name
Spitalul Clinic Prof. Dr. Th. Burghele
City
Bucuresti
ZIP/Postal Code
050653
Country
Romania
Facility Name
Centrul Medical Sf. Pantelimon
City
Pantelimon
Country
Romania
Facility Name
Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Urology of Rosmedtechnology
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava
City
St. Petersburg
ZIP/Postal Code
filial 1 197022
Country
Russian Federation
Facility Name
SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology
City
St. Petersburg
ZIP/Postal Code
filial 1, 197022
Country
Russian Federation
Facility Name
Martinska fakultna nemocnica
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
MILAB s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinica Del Remei - Instituto Medico Tecnologico
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Kliniska provningsenheten
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Medicinsk Rontgen (x-ray only)
City
Malmo
ZIP/Postal Code
211 36
Country
Sweden
Facility Name
Center for Lakemedelsprovning Malmo
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Chang Gung Medical Foundation - Kaohsiung/Department of Surgery
City
Koahsiung Hsien
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Taichung Hospital, Department of Health, Executive Yuan
City
Taichung City
ZIP/Postal Code
403
Country
Taiwan
Facility Name
Taipei Veterans General Hospital (X-Ray Only)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Veterans General Hospital/Department of Surgery
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
32734597
Citation
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091035&StudyName=A%20Study%20To%20Investigate%20Tanezumab%20In%20Patients%20With%20Interstitial%20Cystitis/%20Painful%20Bladder%20Syndrome
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

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