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Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141362
First received: August 30, 2005
Last updated: December 29, 2006
Last verified: December 2006
History of Changes
  Purpose

Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic pain.


Condition Intervention Phase
Pain
 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 Chronic Neuropathic Pain.

Resource links provided by NLM:

Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and efficacy

Estimated Enrollment: 325
Study Start Date: October 2001
Estimated Study Completion Date: August 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 the preceding double-blind BID study in diabetic neuropathy or postherpetic neuralgia.
  • Must have received study medication under double-blind conditions.

Exclusion Criteria:

  • Patients cannot participate if they experienced a serious adverse event during the previous 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: NCT00141362

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141362     History of Changes
Other Study ID Numbers: 1008-000-166
Study First Received: August 30, 2005
Last Updated: December 29, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuralgia
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 June 18, 2013