Back to resultsStudy of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
[S,S]-Reboxetine
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria: Patients must have pain present for more than 3 months after the healing of shingles skin rash. Patients at screening must have a score > or = 40 mm on the pain visual analogue scale. Exclusion Criteria: Patients with poor renal function. Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. Patients with abnormal electrocardiogram.
Sites / Locations
Outcomes
Primary Outcome Measures
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.
Secondary Outcome Measures
- The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00143442
Brief Title
Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
Official Title
A 5-Week, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN), Who Are Gabapentin Treatment Failures.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
184 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
[S,S]-Reboxetine
Primary Outcome Measure Information:
Title
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 5 will be calculated.
Secondary Outcome Measure Information:
Title
- The mean endpoint (week 5) sleep interference score change from baseline - Analysis of the Patient Global Impression of Change - Analysis of the Clinical Global Impression of Change - Analysis of the SF-McGill questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have pain present for more than 3 months after the healing of shingles skin rash.
Patients at screening must have a score > or = 40 mm on the pain visual analogue scale.
Exclusion Criteria:
Patients with poor renal function.
Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
Patients with abnormal electrocardiogram.
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
Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
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