Not Signed In -
Gabapentin |
Neurontin |
Clinical Trial: Study of [S,S]-Reboxetine in Patients with Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Pain | Drug: [S,S]-Reboxetine | Phase II |
MedlinePlus related topics: Pain
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.
Further Study Details:
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
Expected Total Enrollment: 184
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
Expected Total Enrollment: 184
Study start: December 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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 ≥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.
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A6061001
Last Updated: September 1, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00143442
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 1, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00143442
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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