Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: [S,S]-Reboxetine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: - 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: December 2003
Ending date: October 2004
Last updated: August 4, 2006
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