[S,S]-Reboxetine Dose-Range Finding Trial

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[S,S]-Reboxetine

Drug

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

[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)

Important dates

Study start: 2006
Study completion: 2007
First posted: Feb 8, 2006
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed