Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159666

Purpose

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Condition	Intervention	Phase
Post-Herpetic Neuralgia	Drug: pregabalin	Phase IV

MedlinePlus related topics: Shingles

Drug Information available for: Pregabalin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

Further study details as provided by Pfizer:

Primary Outcome Measures:

Estimated Enrollment:	255
Study Start Date:	October 2004
Estimated Study Completion Date:	June 2006

Eligibility

Criteria

Inclusion Criteria:

Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion Criteria:

History of neurolytic or neurosurgical therapy for PHN.
Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159666

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

Study ID Numbers:	A0081004
Study First Received:	September 8, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00159666
Health Authority:	United States: Food and Drug Administration

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 14, 2009