search
Back to results

A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-05089771 150 mg
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Pregabalin 300 mg
PF-05089771 150 mg + Pregabalin 300 mg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18 years to 80 years.
  • Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
  • Presence of ongoing pain due to DPN for at least 6 months.
  • Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.

Exclusion Criteria:

  • Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
  • Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
  • Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
  • Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.

Sites / Locations

  • Clinical Research Consortium Arizona
  • Arizona Research Center
  • Neuro-Pain Medical Center
  • Meridien Research
  • PAB Clinical Research
  • Pulmonary Associates of Brandon (PAB)
  • Meridien Research
  • Clinical Physiology Associates
  • MD Clinical
  • Meridien Research
  • Family Care Specialists
  • Renstar Medical Research
  • Oviedo Medical Research, LLC
  • Meridien Research
  • Meridien Research
  • Metabolic Research Institute, Inc
  • Columbus Regional Research Institute
  • Clinical Research Advantage, Inc
  • Brigham and Women's Hospital
  • Novex Clinical Research, LLC
  • Beacon Clinical Research, LLC
  • Michigan Head Pain and Neurological Institute
  • Clinical Research Consortium
  • The Medical Research Network, LLC
  • New Phase Research and Development
  • Internal Medicine Associates
  • Trinity Clinical Research, LLC
  • KRK Medical Research
  • Nerve and Muscle Center of Texas
  • National Clinical Research - Norfolk, Inc
  • Eastern Virginia Medical School
  • Rainier Clinical Research Center, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PF-05089771

Placebo

Pregabalin

PF-05089771 + Pregabalin

Arm Description

Outcomes

Primary Outcome Measures

Daily Pain Numeric Rating Scale (NRS)
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.

Secondary Outcome Measures

Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Patient's Global Impression of Change Score (PGIC).
Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
Daily Sleep Interference Scale Score (DSIS).
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Total Amount of Rescue Medication Per Week
Total amount of rescue medication participants take per week
Number of Days Participants Take Rescue Medication
Number of days participants take rescue medication per week.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
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; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Fasted Total Cholesterol Values
Percentage Change from Baseline in Fasted Total Cholesterol values
Fasted Low Density Lipoprotein (LDL) Cholesterol
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Plasma Concentration of PF-05089771
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.

Full Information

First Posted
August 11, 2014
Last Updated
March 26, 2017
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT02215252
Brief Title
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
Official Title
A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 10, 2014 (Actual)
Primary Completion Date
July 15, 2015 (Actual)
Study Completion Date
September 28, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PF-05089771
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Arm Title
Pregabalin
Arm Type
Experimental
Arm Title
PF-05089771 + Pregabalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-05089771 150 mg
Intervention Description
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Intervention Description
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 300 mg
Intervention Description
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Intervention Type
Drug
Intervention Name(s)
PF-05089771 150 mg + Pregabalin 300 mg
Intervention Description
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Primary Outcome Measure Information:
Title
Daily Pain Numeric Rating Scale (NRS)
Description
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Time Frame
Baseline, Week 1, Week 2, Week 3 and Week 4
Secondary Outcome Measure Information:
Title
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Description
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Time Frame
Baseline, Week 1, Week 2, Week 3 and Week 4
Title
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Description
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Time Frame
Baseline, Week 1, Week 2, Week 3, and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Description
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2, and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Description
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2 and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Description
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2, and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Description
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2 and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Description
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2 and Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Description
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Time Frame
Baseline, Week 2 and Week 4
Title
Patient's Global Impression of Change Score (PGIC).
Description
Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
Time Frame
Baseline, Week 2, and Week 4
Title
Daily Sleep Interference Scale Score (DSIS).
Description
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Time Frame
Baseline, Week 1, Week 2, Week 3 and Week 4
Title
Total Amount of Rescue Medication Per Week
Description
Total amount of rescue medication participants take per week
Time Frame
Baseline, Week 1, Week 2, Week 3, and Week 4
Title
Number of Days Participants Take Rescue Medication
Description
Number of days participants take rescue medication per week.
Time Frame
Baseline, Week 1, Week 2, Week 3 and Week 4
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
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; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Time Frame
Screening to Day 36, and Day 64
Title
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Description
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Time Frame
Screening, Day 1, Day 15 and Day 29
Title
Fasted Total Cholesterol Values
Description
Percentage Change from Baseline in Fasted Total Cholesterol values
Time Frame
Baseline, Week 2 and Week 4
Title
Fasted Low Density Lipoprotein (LDL) Cholesterol
Description
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Time Frame
Baseline, Week 2 and Week 4
Title
Plasma Concentration of PF-05089771
Description
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
Time Frame
Baseline, Week 2 and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 years to 80 years. Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization. Presence of ongoing pain due to DPN for at least 6 months. Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study. Exclusion Criteria: Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study. Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy. Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities. Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
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
Clinical Research Consortium Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Pulmonary Associates of Brandon (PAB)
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
MD Clinical
City
Hallandale
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Family Care 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
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Metabolic Research Institute, Inc
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Clinical Research Advantage, Inc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novex Clinical Research, LLC
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
New Phase Research and Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Facility Name
Internal Medicine Associates
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Trinity Clinical Research, LLC
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
KRK Medical Research
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Nerve and Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Rainier Clinical Research Center, Inc
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291026&StudyName=A%20Clinical%20Trial%20To%20Evaluate%20PF-05089771%20On%20Its%20Own%20And%20As%20An%20Add-On%20Therapy%20To%20Pregabalin%20%28Lyrica%29%20For%20The%20Treatment%20Of%20Pain%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

We'll reach out to this number within 24 hrs