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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150436
First received: September 6, 2005
Last updated: December 20, 2006
Last verified: December 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Neuralgia
 Drug: Pregabalin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

No publications provided

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

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013