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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143442

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: Shingles

Drug Information available for: Gabapentin Reboxetine Reboxetine mesylate

U.S. FDA Resources

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 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 5 will be calculated.

Secondary Outcome Measures:

- 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

Estimated Enrollment:	184
Study Start Date:	December 2003
Estimated Study Completion Date:	October 2004

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 > 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143442

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Study ID Numbers:	A6061001
Study First Received:	September 1, 2005
Last Updated:	August 4, 2006
ClinicalTrials.gov Identifier:	NCT00143442
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Gabapentin

Peripheral Nervous System Diseases
Neurologic Manifestations
Pain
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009