Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
2 other identifiers
interventional
306
4 countries
61
Brief Summary
This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2011
61 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
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 23, 2015
CompletedJanuary 28, 2021
April 1, 2015
1.9 years
October 17, 2011
October 30, 2014
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
End of Period (includes both Visits 5 and 9)
Secondary Outcomes (22)
Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
End of Period (includes both Visits 5 and 9)
Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)
End of Period (includes both Visits 5 and 9)
Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)
End of Period (includes both Visits 5 and 9)
BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)
End of Period (includes both Visits 5 and 9)
Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
End of Period (includes both Visits 5 and 9)
- +17 more secondary outcomes
Study Arms (2)
1: Pregabalin
EXPERIMENTAL2: Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Type 1 or 2 diabetes with painful neuropathy
- Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
- Meet pre-defined level of pain severity at entrance
You may not qualify if:
- History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
- Participated in a previous or ongoing pregabalin clinical trial
- Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Clinical Research Consortium
Phoenix, Arizona, 85004, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Advanced Podiatry
Phoenix, Arizona, 85032, United States
Precision Trials
Phoenix, Arizona, 85032, United States
The Office of Joshua D. Holland, M.D.
Phoenix, Arizona, 85053, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Center for United Research, Inc.
Lakewood, California, 90712, United States
HealthCare Partners Medical Group
Los Angeles, California, 90015, United States
IDS Pharmacy
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
National Research Institute
Los Angeles, California, 90057, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Neurological Group, PC
New London, Connecticut, 06320, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Meridien Research
Bradenton, Florida, 34208, United States
Meridien Research
Brooksville, Florida, 34601, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Palm Beach Neurological Center,
Palm Beach Gardens, Florida, 33418, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33606, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Columbus Research Foundation
Columbus, Georgia, 31904, United States
Suburban Clinical Research
Chicago, Illinois, 60624, United States
Suburban Clinical Research
Naperville, Illinois, 60564, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Genesis Clinical Research, LLC
Fall River, Massachusetts, 02720, United States
Borgess Diabetes Center
Kalamazoo, Michigan, 49048, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Mirkil Medical Group
Las Vegas, Nevada, 89119, United States
V.Jerome Mirkil, MD
Las Vegas, Nevada, 89119, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Davidson Medical Ministries
Lexington, North Carolina, 27292, United States
Radiant Research (admin office)
Cincinnati, Ohio, 45249, United States
Radiant Research
Columbus, Ohio, 43212, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
The Office of Veronique Sebastian, MD
Oklahoma City, Oklahoma, 73120, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, 16602, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Neurology and Pain Clinic, LLC
Orangeburg, South Carolina, 29118, United States
New Phase Research and Development
Knoxville, Tennessee, 37919, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Houston Neurocare
Houston, Texas, 77030, United States
Centex Research, Inc.
Houston, Texas, 77062, United States
UNARS, s.r.o.
Pelhřimov, 39301, Czechia
Clintrial, s.r.o.
Prague, 100 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Fondazione PTV Policlinico Tor Vergata di Roma
Roma, 00133, Italy
Center for Lakemedelsstudier
Malmo, 211 52, Sweden
Citydiabetes
Stockholm, 111 57, Sweden
Related Publications (1)
Raskin P, Huffman C, Yurkewicz L, Pauer L, Scavone JM, Yang R, Parsons B. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016 Mar;32(3):203-10. doi: 10.1097/AJP.0000000000000254.
PMID: 25968451DERIVED
Related Links
MeSH Terms
Interventions
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 20, 2011
Study Start
December 1, 2011
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
January 28, 2021
Results First Posted
April 23, 2015
Record last verified: 2015-04