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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141362
First Posted: September 1, 2005
Last Update Posted: January 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141362


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

ClinicalTrials.gov Identifier: NCT00141362     History of Changes
Other Study ID Numbers: 1008-000-166
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 1, 2007
Last Verified: December 2006

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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs


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