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An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

Primary Purpose

Cystitis, Interstitial

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-04383119
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 Painful Bladder Syndrome, monoclonal antibody

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female adults at least 18 years of age;
  • Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

  • Less than 6 months since onset of interstitial cystitis symptoms;
  • History of recurrent urinary tract infections, or genitourinary cancer;
  • History of hepatitis B, C or human immunodeficiency virus (HIV);
  • Use of certain drugs given into the bladder up to 1 month prior to study entry.

Sites / Locations

  • Pivotal Research Center
  • Urology Associates of Central California
  • Citrus Valley Medical Research Inc.
  • SD Uro-Research
  • Boulder Medical Center
  • Hartford Hospital, Urogynecology Division
  • Hartford Hospital
  • The Connecticut Clinical Research Center, Urology Specialists PC
  • Waterbury Neurology
  • Connecticut Urological Research at Grove Hill
  • Coastal Connecticut Research, LLC
  • Timothy M. Barczak, MD, LLC
  • Atlanta Center for Medical Research
  • Metropolitan Urology
  • Regional Urology, LLC
  • Chesapeake Urology Research Associates
  • William Beaumont Hospital
  • Michigan Institute of Urology
  • Michigan Institute of Urology
  • Barnes Jewish West County Hospital
  • Washington University, Division of Urologic Surgery
  • Washington University
  • Quality Clinical Research Inc
  • The Arthur Smith Institute for Urology
  • University of Rochester Medical Center
  • Alliance Urology Specialists, PA
  • Tri-State Urologic Services PSC, Inc. dba The Urology Group
  • Parkhurst Research Organization, LLC
  • Triangle Urological Associates
  • Matrix Research, LLC (Administrative Only)
  • The Urology Group
  • Mobley Research Center
  • Integrity Medical Research, LLC
  • Northside Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Average Daily Pain Score at Week 6
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.

Secondary Outcome Measures

Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
The nocturnal frequency per night 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.
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
The nocturnal frequency per night 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. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance.
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain.
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16
The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions consisted of 4 ranked answers from 0-never to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16
The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16
The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturnal and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16
The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16
Participants were asked the following question: "Compared to when you began this trial, how would you rate your interstitial cystitis symptoms now?" Participants responded on 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; where higher scores indicated improvement. Participants who responded as 6 (moderately improved) or 7 (markedly improved) were defined as treatment responders. Number of participants with response based on GRA scale for all scale categories were reported in this outcome measure.
Patient's Global Satisfaction Assessment
Participant global satisfaction was 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 the following question: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response was rated on a 5-point scale where 1=extremely dissatisfied (dissatisfy), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied; where higher scores indicated more satisfaction. Number of participants with each response was reported in this outcome measure.
Patient's Global Preference Assessment at Weeks 6, and 16
Participant global preference was assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery and no treatment. Participants' preference was assessed using following categories: definitely prefer current drug, slightly prefer current drug, no preference, definitely prefer prior treatment and slightly prefer prior treatment. Number of participants under each of the categories was reported in this outcome measure. For previous treatment, a single participant may be represented in more than 1 category.
Patient Willingness to Re-use Medicine Assessment
Participant willingness to re-use study medication was assessed using 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 the following question: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your interstitial cystitis?" Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, and definitely would not want to re-use.
Percentage of Participants Who Use Rescue Medication
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any United States Food and Drug Administration (US FDA) approved commercial product of acetaminophen 500 milligram (mg) tablet/capsule could be taken as rescue medication.
Ratio of Number of Days Rescue Medication Used
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by days rescue medication was used relative to the total number of days participant was in the study.
Average Number of Doses Per Day of Rescue Medication Used
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by doses of rescue medication used relative to the total number of days participant was in the study.
Amount of Rescue Medication Taken Per Day
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by amount of rescue medication (in mg) relative to the total number of days participant was in the study.
Time to First Dose of Rescue Medication as a Proportion of Total Days in Study
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Time to first dose of rescue medication was defined as the time (in days) from the first dose of study drug to the time of first dose of rescue medication use. Results were normalized by days (time [in days] to first dose of rescue medication) relative to the total number of days participant was in the study and reported in terms of proportion of total days in study.
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration
Plasma Total NGF levels were assayed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Urine NGF was not analyzed because no reliable assay method was available for assessing urine NGF.
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration
HB-EGF urine concentration (in picogram per milliliter [pg/mL]) at specified time points is reported here.
Anti-Proliferative Factor (APF) Urine Concentration
APF activity was determined using 3 H-thymidine incorporation assay. The results were expressed as the percentage of inhibition of 3 H-thymidine incorporation in epithelial cells from urine specimens in the presence of anti proliferative factor.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system and any additional assessments necessary to establish baseline status. Clinically significant change in physical examination was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Clinically significant change in vital signs was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Body Weight
Clinically significant change in body weight was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination
Neurological examination included the assessment of cranial nerve function, coordination, reflexes, mental state, motor function, proprioception, gait and station, and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). Clinically significant change in neurologic examination was based on investigator's discretion.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
Clinically significant criteria for ECG abnormality: PR interval (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QRS complex (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QT interval, QT interval corrected using the Fridericia's formula (QTcF) (maximum increase from Baseline of >= 30 to <60; or >=60), QT interval corrected using the Bazett's formula (QTcB) (maximum increase from Baseline of >= 30 to <60; or >=60) and RR interval.
Post-void Residual (PVR) Volume
PVR volume is an objective assessment of the amount of urine (in milliliter) left in the bladder after normal urination and monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (for example, bladder scanner) with the participant in a supine position immediately after voluntary urination.
Number of Participants With Laboratory Abnormalities
Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.
Number of Participants With Presence of Anti-Drug Antibody (ADA)
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme-linked immunosorbent assay (ELISA).
Plasma Concentration of Tanezumab

Full Information

First Posted
January 15, 2008
Last Updated
April 20, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00601484
Brief Title
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
Official Title
A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PF-04383119 FOR THE TREATMENT OF PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2008 (Actual)
Primary Completion Date
April 15, 2009 (Actual)
Study Completion Date
April 15, 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Painful Bladder Syndrome, monoclonal antibody

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04383119
Intervention Description
PF-04383119 200 mcg/kg IV, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo IV, single dose
Primary Outcome Measure Information:
Title
Change From Baseline in Average Daily Pain Score at Week 6
Description
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Here, 'Number analyzed' = participants with available data for each specified category.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16
Description
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Time Frame
Baseline, Week 2, 4, 10, 16
Title
Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16
Description
Participants assessed their average interstitial cystitis pain intensity during the last 24 hours on an 11-point NRS ranging from 0 (no interstitial cystitis pain) to 10 (worst possible interstitial cystitis pain); where higher scores indicated higher pain. The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
Description
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16
Description
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder. Each question in the ICSI was rated on a 0 (no symptoms) to 5 (severe symptoms) scale, with higher scores indicating greater symptom severity. The sum of the individual question ratings was the total score for the ICSI. Total score ranged from 0 (no symptoms) to 20 (severe symptoms), with higher score indicating greater symptom severity.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The micturition frequency per 24 hours was calculated from the sum of voluntary voids divided by the number of diary days over which they were collected.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
Description
The nocturnal frequency per night 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 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16
Description
The nocturnal frequency per night 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. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The incontinence episode frequency per 24 hours was calculated as the sum of any incontinence episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
Description
Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16
Description
Mean voided volume per micturition was calculated as the total urine volume voided (resulting from a toilet [voluntary] void) during the diary period when this was measured, divided by the number of toilet voids over which this occurred.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
Description
Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16
Description
Mean interstitial cystitis pain severity per urinary event (toilet void, accidental urine loss, urgency episode) was calculated as the mean of all pain severities recorded during the diary period when these events were measured. For each urinary event (toilet void, accidental urine loss, urgency episode), participants marked their associated level of pain intensity (or pressure, aching, burning, discomfort) using an 11-point NRS ranging from 0 denoting none (no pain), and 10 denoting worst (pain as bad as you can imagine), where higher scores indicated higher pain. Total mean interstitial cystitis pain severity per urinary event score ranged from 0 (no pain) to 10 worst (pain as bad as you can imagine), where higher scores indicated more pain.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The urinary urgency episode per 24 hours was calculated as the sum of any urgency episodes occurring during the diary period when this was measured, divided by the number of days over which they were recorded. Percent change from baseline was calculated for participants who reported greater than 0 episodes at baseline.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
Average sleep disturbance score was calculated from the sleep disturbance experienced over the previous night. The average sleep disturbance score per night was determined from calculating the mean of all sleep disturbance scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much did the symptoms that you associate with your interstitial cystitis disturb your sleep?" Participants responded on a 5-point scale ranging from 0 (not at all) to 4 (extremely); where higher scores indicated more sleep disturbance. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores of 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16
Description
The average pain score associated with sexual activity was determined from calculating the mean of sexual activity scores in the 7 days prior to each assessment time point. Participants answered the following question: "Over the past 24 hours, how much pain did you experience during or after sexual activity?" Participants responded on a 5-point scale ranging from 0 (no pain) to 4 (extremely painful); where higher scores indicated higher pain. Percent change from baseline was calculated for participants who reported greater than 0 score at baseline.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16
Description
The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions consisted of 4 ranked answers from 0-never to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16
Description
The pelvic pain and urgency/frequency (PUF) was a 12-item questionnaire used to measure the severity of symptoms and the degree to which participants were bothered. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always with higher answers indicating more bothering. Total score was calculated as the sum of symptom score and bother score and ranged from 0 (no symptoms/bother) to 35 (higher symptom severity/bother), where a higher score indicated greater symptom severity and higher bother from pelvic pain and frequency.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16
Description
The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturnal and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16
Description
The ICPI contained 4 questions that measured how problematic the symptoms (urinary urgency, urinary frequency, nocturia and pain/burning/discomfort/pressure in the bladder) were for the participant. Each question in the ICPI was rated on a 0-4 scale, where 0= no problem and 4= big problem. The sum of the individual question ratings was the total score for the ICPI. Total score ranged from 0 (no problem) to 16 (big problem), with higher score indicating greater problematic symptom.
Time Frame
Baseline, Week 2, 4, 6, 10, 16
Title
Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16
Description
Participants were asked the following question: "Compared to when you began this trial, how would you rate your interstitial cystitis symptoms now?" Participants responded on 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; where higher scores indicated improvement. Participants who responded as 6 (moderately improved) or 7 (markedly improved) were defined as treatment responders. Number of participants with response based on GRA scale for all scale categories were reported in this outcome measure.
Time Frame
Week 6, 16
Title
Patient's Global Satisfaction Assessment
Description
Participant global satisfaction was 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 the following question: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response was rated on a 5-point scale where 1=extremely dissatisfied (dissatisfy), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied; where higher scores indicated more satisfaction. Number of participants with each response was reported in this outcome measure.
Time Frame
Week 6, 16
Title
Patient's Global Preference Assessment at Weeks 6, and 16
Description
Participant global preference was assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using study medication. Participant reported previous treatment under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery and no treatment. Participants' preference was assessed using following categories: definitely prefer current drug, slightly prefer current drug, no preference, definitely prefer prior treatment and slightly prefer prior treatment. Number of participants under each of the categories was reported in this outcome measure. For previous treatment, a single participant may be represented in more than 1 category.
Time Frame
Week 6, 16
Title
Patient Willingness to Re-use Medicine Assessment
Description
Participant willingness to re-use study medication was assessed using 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 the following question: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your interstitial cystitis?" Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, and definitely would not want to re-use.
Time Frame
Week 6, 16
Title
Percentage of Participants Who Use Rescue Medication
Description
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any United States Food and Drug Administration (US FDA) approved commercial product of acetaminophen 500 milligram (mg) tablet/capsule could be taken as rescue medication.
Time Frame
Baseline up to Week 16
Title
Ratio of Number of Days Rescue Medication Used
Description
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by days rescue medication was used relative to the total number of days participant was in the study.
Time Frame
Baseline up to Week 16
Title
Average Number of Doses Per Day of Rescue Medication Used
Description
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by doses of rescue medication used relative to the total number of days participant was in the study.
Time Frame
Baseline up to Week 16
Title
Amount of Rescue Medication Taken Per Day
Description
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Results were normalized by amount of rescue medication (in mg) relative to the total number of days participant was in the study.
Time Frame
Baseline up to Week 16
Title
Time to First Dose of Rescue Medication as a Proportion of Total Days in Study
Description
In case of inadequate pain relief or worsening symptoms of interstitial cystitis, any US FDA approved commercial product of acetaminophen 500 mg tablet/capsule could be taken as rescue medication. Time to first dose of rescue medication was defined as the time (in days) from the first dose of study drug to the time of first dose of rescue medication use. Results were normalized by days (time [in days] to first dose of rescue medication) relative to the total number of days participant was in the study and reported in terms of proportion of total days in study.
Time Frame
Baseline up to Week 16
Title
Plasma and Urine Total Nerve Growth Factor (NGF) Concentration
Description
Plasma Total NGF levels were assayed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Urine NGF was not analyzed because no reliable assay method was available for assessing urine NGF.
Time Frame
Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
Title
Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration
Description
HB-EGF urine concentration (in picogram per milliliter [pg/mL]) at specified time points is reported here.
Time Frame
Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
Title
Anti-Proliferative Factor (APF) Urine Concentration
Description
APF activity was determined using 3 H-thymidine incorporation assay. The results were expressed as the percentage of inhibition of 3 H-thymidine incorporation in epithelial cells from urine specimens in the presence of anti proliferative factor.
Time Frame
Day 1 (1 hour pre-dose), Week 2, 4, 6, 10, 16
Title
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
Description
Physical examination included the examination of general appearance, skin, neck, eyes, ears, nose, throat, cardiovascular assessment including rhythm, and presence of other cardiac abnormalities (for example gallops, murmurs, cardiomegaly), respiratory system, gastrointestinal system, genitourinary system, musculoskeletal system and any additional assessments necessary to establish baseline status. Clinically significant change in physical examination was based on investigator's discretion.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description
Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Clinically significant change in vital signs was based on investigator's discretion.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Change From Baseline in Body Weight
Description
Clinically significant change in body weight was based on investigator's discretion.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination
Description
Neurological examination included the assessment of cranial nerve function, coordination, reflexes, mental state, motor function, proprioception, gait and station, and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). Clinically significant change in neurologic examination was based on investigator's discretion.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)
Description
Clinically significant criteria for ECG abnormality: PR interval (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QRS complex (maximum increase from Baseline of >=25% [only if Baseline value was greater than 200 millisecond] or otherwise 50%), QT interval, QT interval corrected using the Fridericia's formula (QTcF) (maximum increase from Baseline of >= 30 to <60; or >=60), QT interval corrected using the Bazett's formula (QTcB) (maximum increase from Baseline of >= 30 to <60; or >=60) and RR interval.
Time Frame
Baseline up to Week 16
Title
Post-void Residual (PVR) Volume
Description
PVR volume is an objective assessment of the amount of urine (in milliliter) left in the bladder after normal urination and monitored whether the active treatment had an adverse effect on lower urinary tract voiding function. The PVR volume was assessed using trans-abdominal ultrasound (for example, bladder scanner) with the participant in a supine position immediately after voluntary urination.
Time Frame
Baseline, Week 2, 6, 16
Title
Number of Participants With Laboratory Abnormalities
Description
Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Presence of Anti-Drug Antibody (ADA)
Description
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 1, Week 4, 6, 16
Title
Plasma Concentration of Tanezumab
Time Frame
0 hour (pre-dose), 1, 2 hours post-dose on Day 1; and at Week 2, 4, 6, 10, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults at least 18 years of age; Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level. Exclusion Criteria: Less than 6 months since onset of interstitial cystitis symptoms; History of recurrent urinary tract infections, or genitourinary cancer; History of hepatitis B, C or human immunodeficiency virus (HIV); Use of certain drugs given into the bladder up to 1 month prior to study entry.
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
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Urology Associates of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Citrus Valley Medical Research Inc.
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
SD Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Boulder Medical Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Hartford Hospital, Urogynecology Division
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
The Connecticut Clinical Research Center, Urology Specialists PC
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Waterbury Neurology
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Connecticut Urological Research at Grove Hill
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Timothy M. Barczak, MD, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Michigan Institute of Urology
City
Utica
State/Province
Michigan
ZIP/Postal Code
48313
Country
United States
Facility Name
Barnes Jewish West County Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Washington University, Division of Urologic Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Quality Clinical Research Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
The Arthur Smith Institute for Urology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
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
Alliance Urology Specialists, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
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
Parkhurst Research Organization, LLC
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Triangle Urological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Matrix Research, LLC (Administrative Only)
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
Mobley Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Northside Internal Medicine
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

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=A4091010&StudyName=An%20Effectiveness%20and%20Safety%20Study%20of%20PF-04383119%20for%20the%20Treatment%20of%20Pain%20in%20Interstitial%20Cystitis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

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