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[S,S]-Reboxetine Dose-Range Finding Trial

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: February 7, 2006
Last updated: June 7, 2011
Last verified: June 2011
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

Condition Intervention Phase
Drug: [S,S]-Reboxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: [S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

Secondary Outcome Measures:
  • - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey

Estimated Enrollment: 280
Study Start Date: March 2006
Study Completion Date: February 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 significant renal and hepatic impairment
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
  • Patients with clinically abnormal electrocardiogram
  Contacts and Locations
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Please refer to this study by its identifier: NCT00288652

  Show 79 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00288652     History of Changes
Other Study ID Numbers: A6061026 
Study First Received: February 7, 2006
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on October 21, 2016