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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.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00141375
  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 III

MedlinePlus related topics: Spinal Cord Injuries
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 to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.

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
Pfizer Investigational Site
NSW, Australia
Australia, New South Wales
Pfizer Investigational Site
St. Leonards, New South Wales, Australia, 2065
Pfizer Investigational Site
Little Bay, New South Wales, Australia, 2036
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
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: 1008-000-202
Study First Received: August 30, 2005
Last Updated: January 9, 2008
ClinicalTrials.gov Identifier: NCT00141375  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Pregabalin
 Disorders of Environmental Origin
Central Nervous System Diseases
Pain
Trauma, Nervous System

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

ClinicalTrials.gov processed this record on January 13, 2009



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