A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
1 other identifier
interventional
123
1 country
27
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2008
27 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
November 2, 2007
CompletedFirst Posted
Study publicly available on registry
November 5, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
January 5, 2011
CompletedJanuary 25, 2021
April 1, 2011
1.9 years
November 2, 2007
December 7, 2010
January 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Summary of Adverse Events
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.
53 weeks
Secondary Outcomes (5)
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
From baseline to 52 weeks or study discontinuation (Study Endpoint)
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
From baseline to 52 weeks or study discontinuation (Study Endpoint)
Study Arms (1)
pregabalin
EXPERIMENTALInterventions
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Date-shi, Fukushima, Japan
Pfizer Investigational Site
Nihommatsu, Fukushima, Japan
Pfizer Investigational Site
Shirakawa-shi, Fukushima, Japan
Pfizer Investigational Site
Sukagawa, Fukushima, Japan
Pfizer Investigational Site
Kamakura, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Matsumoto, Nagano, Japan
Pfizer Investigational Site
Ueda, Nagano, Japan
Pfizer Investigational Site
Beppu, Oita Prefecture, Japan
Pfizer Investigational Site
Yamada, Okayama-ken, Japan
Pfizer Investigational Site
Naha, Okinawa, Japan
Pfizer Investigational Site
Tomishiro, Okinawa, Japan
Pfizer Investigational Site
Urazoe, Okinawa, Japan
Pfizer Investigational Site
Hirano-ku, Osaka, Japan
Pfizer Investigational Site
Suminoe-ku, Osaka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Oyama-shi, Tochigi, Japan
Pfizer Investigational Site
Arakawa City, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Ohta-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Ōita, Japan
Pfizer Investigational Site
Tokushima, Japan
Related Publications (1)
Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011 Nov 30;2(6):457-63. doi: 10.1111/j.2040-1124.2011.00122.x.
PMID: 24843530DERIVED
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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2007
First Posted
November 5, 2007
Study Start
February 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
January 25, 2021
Results First Posted
January 5, 2011
Record last verified: 2011-04