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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288652
First received: February 7, 2006
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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
Pain
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)

Resource links provided by NLM:


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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288652

  Show 79 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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:
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014