- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00553280
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
Study Overview
Study Type
Interventional
Enrollment (Actual)
123
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
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Fukuoka, Japan
- Pfizer Investigational Site
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Oita, Japan
- Pfizer Investigational Site
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Tokushima, Japan
- Pfizer Investigational Site
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Aichi
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Nagoya, Aichi, Japan
- Pfizer Investigational Site
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Fukushima
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Date-shi, Fukushima, Japan
- Pfizer Investigational Site
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Nihonmatsu, Fukushima, Japan
- Pfizer Investigational Site
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Shirakawa-shi, Fukushima, Japan
- Pfizer Investigational Site
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Sukagawa, Fukushima, Japan
- Pfizer Investigational Site
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Kanagawa
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Kamakura, Kanagawa, Japan
- Pfizer Investigational Site
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Yokohama, Kanagawa, Japan
- Pfizer Investigational Site
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Miyagi
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Sendai, Miyagi, Japan
- Pfizer Investigational Site
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Nagano
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Matsumoto, Nagano, Japan
- Pfizer Investigational Site
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Ueda, Nagano, Japan
- Pfizer Investigational Site
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Oita
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Beppu, Oita, Japan
- Pfizer Investigational Site
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Okayama
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Yamada, Okayama, Japan
- Pfizer Investigational Site
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Okinawa
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Naha, Okinawa, Japan
- Pfizer Investigational Site
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Tomishiro, Okinawa, Japan
- Pfizer Investigational Site
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Urazoe, Okinawa, Japan
- Pfizer Investigational Site
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Osaka
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Hirano-ku, Osaka, Japan
- Pfizer Investigational Site
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Suminoe-ku, Osaka, Japan
- Pfizer Investigational Site
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Shizuoka
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Sunto-gun, Shizuoka, Japan
- Pfizer Investigational Site
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Tochigi
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Oyama-shi, Tochigi, Japan
- Pfizer Investigational Site
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Tokyo
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Arakawa, Tokyo, Japan
- Pfizer Investigational Site
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Bunkyo-ku, Tokyo, Japan
- Pfizer Investigational Site
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Chiyoda-ku, Tokyo, Japan
- Pfizer Investigational Site
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Ohta-ku, Tokyo, Japan
- Pfizer Investigational Site
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Shibuya-ku, Tokyo, Japan
- 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:
- Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
- Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study
Exclusion Criteria:
- Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
- Patients exhibiting treatment non-compliance in the preceding study (A0081163)
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: pregabalin
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Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of Adverse Events
Time Frame: 53 weeks
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Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation.
Participants are counted only once per treatment in each row.
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53 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
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The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint.
Sensory score ranges from 0-33.
Higher scores indicate more severe pain.
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From baseline to 52 weeks or study discontinuation (Study Endpoint)
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Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
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The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint.
Affective score ranges from 0-12.
Higher scores indicate more severe pain.
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From baseline to 52 weeks or study discontinuation (Study Endpoint)
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Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
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The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint.
Total score ranges from 0-45.
Higher scores indicate more severe pain.
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From baseline to 52 weeks or study discontinuation (Study Endpoint)
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Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
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The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint.
Visual Analogue Scale Score ranges from 0-100 mm.
Higher scores indicate more severe pain.
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From baseline to 52 weeks or study discontinuation (Study Endpoint)
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Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
Time Frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)
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The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint.
Present pain intensity score ranges from 0-5.
Higher scores indicate more severe pain.
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From baseline to 52 weeks or study discontinuation (Study Endpoint)
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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
February 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
November 2, 2007
First Submitted That Met QC Criteria
November 2, 2007
First Posted (Estimate)
November 4, 2007
Study Record Updates
Last Update Posted (Actual)
January 25, 2021
Last Update Submitted That Met QC Criteria
January 21, 2021
Last Verified
April 1, 2011
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
- A0081164
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.
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