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

Pfizer184 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Pain

Interventions

[S,S]-ReboxetineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

- 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

Data from ClinicalTrials.gov

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