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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00143442

First received: September 1, 2005

Last updated: August 4, 2006

Last verified: August 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

August 4, 2006

Start Date ^ICMJE

December 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00143442 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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

Original Secondary Outcome Measures ^ICMJE

- 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: [S,S]-Reboxetine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

184

Completion Date

October 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00143442

Other Study ID Numbers ^ICMJE

A6061001

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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