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

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ClinicalTrials.gov Identifier: NCT00141375
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Pregabalin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : August 2002
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin




Primary Outcome Measures :
  1. Safety and Efficacy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): 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

ClinicalTrials.gov Identifier: NCT00141375     History of Changes
Other Study ID Numbers: 1008-000-202
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
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