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)
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
2 other identifiers
interventional
141
1 country
32
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2014
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedStudy Start
First participant enrolled
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2015
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedMay 5, 2017
March 1, 2017
8 months
August 11, 2014
July 12, 2016
March 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 1, Week 2, Week 3 and Week 4
Secondary Outcomes (17)
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Baseline, Week 1, Week 2, Week 3 and Week 4
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Baseline, Week 1, Week 2, Week 3, and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Baseline, Week 2, and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Baseline, Week 2 and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Baseline, Week 2, and Week 4
- +12 more secondary outcomes
Study Arms (4)
PF-05089771
EXPERIMENTALPlacebo
EXPERIMENTALPregabalin
EXPERIMENTALPF-05089771 + Pregabalin
EXPERIMENTALInterventions
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Clinical Research Consortium Arizona
Phoenix, Arizona, 85003, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Meridien Research
Bradenton, Florida, 34208, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Pulmonary Associates of Brandon (PAB)
Brandon, Florida, 33511, United States
Meridien Research
Brooksville, Florida, 34601, United States
Clinical Physiology Associates
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
Meridien Research
Lakeland, Florida, 33805, United States
Family Care Specialists
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33634, United States
Metabolic Research Institute, Inc
West Palm Beach, Florida, 33401, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Clinical Research Advantage, Inc
Evansville, Indiana, 47714, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Novex Clinical Research, LLC
New Bedford, Massachusetts, 02740, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
New Phase Research and Development
Knoxville, Tennessee, 37919, United States
Internal Medicine Associates
Tullahoma, Tennessee, 37388, United States
Trinity Clinical Research, LLC
Tullahoma, Tennessee, 37388, United States
KRK Medical Research
Arlington, Texas, 76012, United States
Nerve and Muscle Center of Texas
Houston, Texas, 77030, United States
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, 23502, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510, United States
Rainier Clinical Research Center, Inc
Renton, Washington, 98057, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 13, 2014
Study Start
November 10, 2014
Primary Completion
July 15, 2015
Study Completion
September 28, 2015
Last Updated
May 5, 2017
Results First Posted
May 5, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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