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To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141375
First received: August 30, 2005
Last updated: January 9, 2008
Last verified: January 2008
History of Changes
  Purpose

To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.


Condition Intervention Phase
Neuropathic 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 to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.

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: 132
Study Start Date: August 2002
Study Completion Date: January 2006
  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 of the preceding double-blind BID study in central pain following spinal cord injury.
  • 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: NCT00141375

Locations
Australia, New South Wales
Pfizer Investigational Site
Little Bay, New South Wales, Australia, 2036
Pfizer Investigational Site
St. Leonards, New South Wales, Australia, 2065
Pfizer Investigational Site
Warrawong, New South Wales, Australia, 2502
Australia, Queensland
Pfizer Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Pfizer Investigational Site
Shenton Park, Western Australia, Australia, 6008
Australia
Pfizer Investigational Site
NSW, Australia
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141375     History of Changes
Other Study ID Numbers: 1008-000-202
Study First Received: August 30, 2005
Last Updated: January 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
 Wounds and Injuries
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 19, 2013