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

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143442
• Other study ID #: A6061001
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: August 4, 2006
• Start date: December 2003
• Est. completion date: October 2004

Study information

• Verified date: August 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neuralgia, Postherpetic
• Pain

Intervention

Drug:
• [S,S]-Reboxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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