A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00394901

Purpose

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Condition	Intervention	Phase
Neuralgia, Postherpetic	Drug: pregabalin	Phase III

MedlinePlus related topics: Shingles

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

Further study details as provided by Pfizer:

Primary Outcome Measures:

Numerical rating scale for pain caused by postherpetic neuralgia after 13-week treatment of pregabalin/placebo.

Secondary Outcome Measures:

Daily Sleep Interference Diary, Short-form McGill Pain Questionnaire, Medical Outcomes Study (MOS)-Sleep Scale for sleep, Patient Global Impression of Change, Clinical Global Impression of Change, SF-36 Health Survey.

Enrollment:	372
Study Start Date:	September 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Visual Analogue Scale (VAS) of pain is higher than 40 mm.
Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Exclusion Criteria:

Malignancy within the past 2 years.
Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
Skin conditions in the affected dermatome that could alter sensation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394901

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081120
Study First Received:	October 31, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00394901
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Pregabalin
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009