- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159731
Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy
The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
160
Phase
- Phase 4
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
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Pfizer Investigational Site
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California
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La Jolla, California, United States, 92037
- Pfizer Investigational Site
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Torrance, California, United States, 90502
- Pfizer Investigational Site
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Torrance, California, United States, 90509
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, United States, 80218
- Pfizer Investigational Site
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Florida
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Ocala, Florida, United States, 34471
- Pfizer Investigational Site
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Ocala, Florida, United States, 34474
- Pfizer Investigational Site
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Palm Beach Gardens, Florida, United States, 33410
- Pfizer Investigational Site
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Sunrise, Florida, United States, 33351
- Pfizer Investigational Site
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West Palm Beach, Florida, United States, 33401
- Pfizer Investigational Site
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West Palm Beach, Florida, United States, 33407
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68131
- Pfizer Investigational Site
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Omaha, Nebraska, United States, 68116
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89102
- Pfizer Investigational Site
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New Jersey
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Englewood, New Jersey, United States, 07631
- Pfizer Investigational Site
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New Brunswick, New Jersey, United States, 08903
- Pfizer Investigational Site
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New York
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Albany, New York, United States, 12205
- Pfizer Investigational Site
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Rochester, New York, United States, 14642
- Pfizer Investigational Site
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Rochester, New York, United States, 14618
- Pfizer Investigational Site
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North Carolina
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Greenville, North Carolina, United States, 27834
- Pfizer Investigational Site
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Ohio
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Toledo, Ohio, United States, 43623
- Pfizer Investigational Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75230
- Pfizer Investigational Site
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Dallas, Texas, United States, 75246
- Pfizer Investigational Site
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Houston, Texas, United States, 77030
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84132
- Pfizer Investigational Site
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Salt Lake City, Utah, United States, 84108
- Pfizer Investigational Site
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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:
- Adults with Type 1 or 2 diabetes
- Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months
Exclusion Criteria:
- Patients must not be in poor or unstable health.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Adverse events
|
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.
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
January 1, 2005
Study Completion
May 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 20, 2021
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- 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
- A0081036
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 Peripheral Neuropathy
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Pamlab, L.L.C.HealthCore, Inc.CompletedDiabetic Peripheral Neuropathy (DPN)United States
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Riphah International UniversityRecruitingDiabetic Peripheral Neuropathy (DPN)Pakistan
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Tanta UniversityCompletedDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Painful Diabetic Neuropathy | Autonomic Neuropathy | Diabetic Polyneuropathy | Small Fiber NeuropathyEgypt
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University of PlymouthNot yet recruitingDiabetic Peripheral Neuropathy | Painful Diabetic Neuropathy
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Wuhan Central HospitalWuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China; Wuhan...RecruitingDiabetic Peripheral Neuropathy Type 2China
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownDiabetic Peripheral Neuropathy
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Hawler Medical UniversityUnknownDiabetic Peripheral NeuropathyIraq
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Fengmei LianPeking Union Medical College Hospital; Huashan Hospital; Chengdu University of... and other collaboratorsUnknownDiabetic Peripheral Neuropathy Type 2China
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Tanta UniversityActive, not recruiting
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October 6 UniversityCompletedDiabetic Neuropathy PeripheralEgypt
Clinical Trials on Pregabalin
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Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
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Jiangsu HengRui Medicine Co., Ltd.UnknownPostherpetic NeuralgiaChina
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Hamilton Health Sciences CorporationMcMaster UniversityTerminated
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EMSRecruitingNeuropathic PainBrazil
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The First Hospital of Jilin UniversityCompletedPain, Postoperative | Arthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipChina
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Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Janssen-Cilag Ltd.Completed
-
University of British ColumbiaJuvenile Diabetes Research FoundationUnknown
-
Ziauddin UniversityCompletedPain, Nerve | Prolapsed Intervertebral DiscPakistan