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Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.
This study has been completed.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00141362
  Purpose

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


Condition Intervention Phase
Pain
Drug: Pregabalin
Phase III

Drug Information available for: Pregabalin
U.S. FDA Resources
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 Chronic Neuropathic Pain.

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

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

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

Study placed in the following topic categories:
Pregabalin
Pain

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009