[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

Pfizer1 site in 1 country280 target enrollmentMarch 2006

ConditionsPain

Drugs[S,S]-Reboxetine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pain
Sponsor: Pfizer
Enrollment: 280
Locations: 1
Primary Endpoint: The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

February 2007

Last Updated

14 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 \>/=40 mm on the pain visual analogue scale

Exclusion Criteria

•Patients with significant renal and hepatic impairment
•Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
•Patients with clinically 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 14 will be calculated

Secondary Outcomes

- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey