Back to resultsTo Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Primary Purpose
Diabetic Neuropathy, Painful
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful
Eligibility Criteria
Inclusion Criteria: Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. Exclusion Criteria: Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety Efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150423
Brief Title
To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Official Title
An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate the safety and efficacy of pregabalin in patients with painful diabetic peripheral neuropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
384 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Safety Efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have met the inclusion criteria for the preceding double-blind BID study in painful diabetic peripheral neuropathy
Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.
Exclusion Criteria:
Patients may not participate if they experienced a serious adverse event during the preceding double-blind BID study which was determined to be related to the study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.
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