Back to resultsTo Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria: Must have met the inclusion criteria of the preceding double-blind BID study in central pain following spinal cord injury. Must have received study medication under double-blind conditions. Exclusion Criteria: Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Safety and Efficacy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00141375
Brief Title
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
Official Title
An Open-Label Extension to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Safety and 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 of the preceding double-blind BID study in central pain following spinal cord injury.
Must have received study medication under double-blind conditions.
Exclusion Criteria:
Patients cannot participate if they experienced a serious adverse event during the previous 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
Facility Information:
Facility Name
Pfizer Investigational Site
City
Little Bay
State/Province
New South Wales
ZIP/Postal Code
2036
Country
Australia
Facility Name
Pfizer Investigational Site
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Warrawong
State/Province
New South Wales
ZIP/Postal Code
2502
Country
Australia
Facility Name
Pfizer Investigational Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Pfizer Investigational Site
City
Shenton Park
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Pfizer Investigational Site
City
NSW
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
We'll reach out to this number within 24 hrs