To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

This study has been completed.

First Received: September 6, 2005 Last Updated: December 20, 2006 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150436

Purpose

To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.

Condition	Intervention	Phase
Neuralgia	Drug: Pregabalin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia

Resource links provided by NLM:

MedlinePlus related topics: Shingles

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety Efficacy

Estimated Enrollment:	276
Study Start Date:	February 2002
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia
Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks.

Exclusion Criteria:

Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150436

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	1008-198
Study First Received:	September 6, 2005
Last Updated:	December 20, 2006
ClinicalTrials.gov Identifier:	NCT00150436 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Pregabalin

Neurologic Manifestations
Pain
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Neuralgia, Postherpetic
Neuralgia
Nervous System Diseases
Physiological Effects of Drugs
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Neuromuscular Diseases

Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009