Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures

August 4, 2006 updated by: Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

184

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

August 8, 2006

Last Update Submitted That Met QC Criteria

August 4, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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