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

Neuropathic Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141375
• Other study ID #: 1008-000-202
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: January 9, 2008
• Start date: August 2002
• Est. completion date: January 2006

Study information

• Verified date: January 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

Drug:
• Pregabalin

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	Little Bay	New South Wales
Australia	Pfizer Investigational Site	NSW
Australia	Pfizer Investigational Site	Shenton Park	Western Australia
Australia	Pfizer Investigational Site	St. Leonards	New South Wales
Australia	Pfizer Investigational Site	Warrawong	New South Wales
Australia	Pfizer Investigational Site	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Efficacy