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.

Pfizer0 sites184 target enrollmentDecember 2003

ConditionsPain

Drugs[S,S]-Reboxetine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pain
Sponsor: Pfizer
Enrollment: 184
Primary Endpoint: 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.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

October 2004

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

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.

Outcomes

Primary Outcomes

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 Outcomes

- 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