A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)

• Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months

• Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

• Pregabalin use in the last 60 days, prior intolerance to pregabalin

• Creatinine clearance <60 mL/min.

• White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.

• Abuse of drugs or alcohol

• Unstable medial conditions

• Clinically significant abnormal electrocardiogram (ECG).

• Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.