- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143156
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.
Study Overview
Study Type
Interventional
Enrollment
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ponce, Puerto Rico, 00716
- Pfizer Investigational Site
-
-
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35406
- Pfizer Investigational Site
-
-
Arizona
-
Phoenix, Arizona, United States, 85023
- Pfizer Investigational Site
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Pfizer Investigational Site
-
-
California
-
La Mesa, California, United States, 91942
- Pfizer Investigational Site
-
Los Gatos, California, United States, 95032-3739
- Pfizer Investigational Site
-
Northridge, California, United States, 91325
- Pfizer Investigational Site
-
Tustin, California, United States, 92780
- Pfizer Investigational Site
-
Walnut Creek, California, United States, 94598
- Pfizer Investigational Site
-
-
Colorado
-
Boulder, Colorado, United States, 80304
- Pfizer Investigational Site
-
Wheat Ridge, Colorado, United States, 80033
- Pfizer Investigational Site
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Pfizer Investigational Site
-
-
Florida
-
Clearwater, Florida, United States, 33761
- Pfizer Investigational Site
-
Hollywood, Florida, United States, 33021
- Pfizer Investigational Site
-
Ocala, Florida, United States, 34471
- Pfizer Investigational Site
-
Tampa, Florida, United States, 33606
- Pfizer Investigational Site
-
West Palm Beach, Florida, United States, 33407-2450
- Pfizer Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- Pfizer Investigational Site
-
Atlanta, Georgia, United States, 30327
- Pfizer Investigational Site
-
Atlanta, Georgia, United States, 30303
- Pfizer Investigational Site
-
Decatur, Georgia, United States, 30033
- Pfizer Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Pfizer Investigational Site
-
Chicago, Illinois, United States, 60610
- Pfizer Investigational Site
-
Peoria, Illinois, United States, 61602
- Pfizer Investigational Site
-
Springfield, Illinois, United States, 62704
- Pfizer Investigational Site
-
-
Indiana
-
Indianapolis, Indiana, United States, 46250
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Pfizer Investigational Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21204
- Pfizer Investigational Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Pfizer Investigational Site
-
Boston, Massachusetts, United States, 02215
- Pfizer Investigational Site
-
Springfield, Massachusetts, United States, 01104
- Pfizer Investigational Site
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- Pfizer Investigational Site
-
Tupelo, Mississippi, United States, 38803-4087
- Pfizer Investigational Site
-
-
Missouri
-
Jefferson City, Missouri, United States, 65109
- Pfizer Investigational Site
-
Saint Louis, Missouri, United States, 63141
- Pfizer Investigational Site
-
-
Nebraska
-
Omaha, Nebraska, United States, 68116-6465
- Pfizer Investigational Site
-
-
New Jersey
-
Englewood, New Jersey, United States, 07631
- Pfizer Investigational Site
-
Shrewsbury, New Jersey, United States, 07702
- Pfizer Investigational Site
-
-
New York
-
New Hyde Park, New York, United States, 11042
- Pfizer Investigational Site
-
New York, New York, United States, 10032
- Pfizer Investigational Site
-
New York, New York, United States, 10022-1009
- Pfizer Investigational Site
-
-
Ohio
-
Kettering, Ohio, United States, 45429
- Pfizer Investigational Site
-
Toledo, Ohio, United States, 43623
- Pfizer Investigational Site
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104-5428
- Pfizer Investigational Site
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 02886
- Pfizer Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- Pfizer Investigational Site
-
-
Texas
-
Dallas, Texas, United States, 75390-8858
- Pfizer Investigational Site
-
Frisco, Texas, United States, 75034
- Pfizer Investigational Site
-
Houston, Texas, United States, 77030
- Pfizer Investigational Site
-
San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, United States, 78207
- Pfizer Investigational Site
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- Pfizer Investigational Site
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- Pfizer Investigational Site
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females at least 18 years of age, of any ethnic origin
- Type 1 or 2 diabetes mellitus
- Pain score greater than or equal to 4 on the 11-point numeric pain rating scale
Exclusion Criteria:
- Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.
|
Secondary Outcome Measures
Outcome Measure |
---|
End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
- Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018. Erratum In: PLoS One. 2019 Feb 26;14(2):e0212959.
- Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
- Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
- Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 21, 2021
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Neuralgia
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Neuropathies
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
WinSanTor, IncCompletedPeripheral Neuropathy | Painful Diabetic Neuropathy | Diabetic Neuropathies, PainfulCanada
-
Maastricht University Medical CenterCompletedPainful Diabetic Neuropathy | Diabetic Neuropathies, Painful | Neuralgia, DiabeticNetherlands
-
Helixmith Co., Ltd.CompletedPainful Diabetic NeuropathiesUnited States, Korea, Republic of
-
Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
-
Corporacion Parc TauliCompletedDiabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications NeurologicalPakistan
-
University Medical Centre LjubljanaUnknown
-
Timothy J. Best Medicine Professional CorporationThe Physicians' Services Incorporated FoundationCompleted
-
AbbVie (prior sponsor, Abbott)CompletedDiabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, DiabeticUnited States, Canada, France, Germany, Italy, Mexico, Puerto Rico
-
Eva PharmaMARC-CRORecruiting
Clinical Trials on pregabalin
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownPostherpetic NeuralgiaChina
-
EMSRecruitingNeuropathic PainBrazil
-
Hamilton Health Sciences CorporationMcMaster UniversityTerminated
-
Janssen-Cilag Ltd.Completed
-
The First Hospital of Jilin UniversityCompletedPain, Postoperative | Arthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipChina
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
University of British ColumbiaJuvenile Diabetes Research FoundationUnknown
-
Ziauddin UniversityCompletedPain, Nerve | Prolapsed Intervertebral DiscPakistan