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

Condition(s) targeted: Neuralgia; Spinal Cord Injuries

Intervention: pregabalin (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The mean of all post-baseline scores derived from subject's daily pain diary, where pain is measured on an 11-point Numerical Rating Scale (NRS-Pain), observed up to a 17-week period.

Secondary outcome:

Weekly mean pain score changes from baseline up to 16 weeks

30% and 50% responder rates in reduction of pain from baseline up to 16 weeks

The Patient Global Impression of Change score measured at treatment termination after a treatment period of up to 16 weeks

Weekly mean sleep interference score changes from baseline up to 16 weeks

The modified Brief Pain Inventory Interference Scale score changes from baseline up to 17 weeks

The Quantitative Assessment of Neuropathic Pain score changes from baseline up to 1 7 weeks

Endpoint mean sleep interference score

Neuropathic Pain Symptom Inventory

The Hospital Anxiety and Depression Scale score changes from baseline up to 17 weeks

The Medical Outcomes Study Sleep Scale score changes from baseline up to 16 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- At least 4 completed pain diaries with an average daily pain score of at least 4

during the 7 days prior to randomization.

- The pain is a chronic unilateral or bilateral, central, below level of neurological

injury neuropathic pain, i. e., pain persisted continuously for at least 3 months or with remissions and relapses for at least 6 months and to have started after spinal cord injury; the central nervous system.

Exclusion Criteria:

- 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Phoenix, Arizona 85016, United States; Not yet recruiting

Pfizer Investigational Site, Phoenix, Arizona 85027, United States; Not yet recruiting

Pfizer Investigational Site, Phoenix, Arizona 85050, United States; Not yet recruiting

Pfizer Investigational Site, Phoenix, Arizona 85004, United States; Not yet recruiting

Pfizer Investigational Site, Fresno, California 93710, United States; Recruiting

Pfizer Investigational Site, San Jose, California 95128, United States; Not yet recruiting

Pfizer Investigational Site, San Jose, California 95128-0000, United States; Not yet recruiting

Pfizer Investigational Site, Long Beach, California 90806, United States; Not yet recruiting

Pfizer Investigational Site, Fairfield, Connecticut 06824, United States; Not yet recruiting

Pfizer Investigational Site, Washington, District of Columbia 20017, United States; Not yet recruiting

Pfizer Investigational Site, Orlando, Florida 32806, United States; Not yet recruiting

Pfizer Investigational Site, Chicago, Illinois 60611, United States; Not yet recruiting

Pfizer Investigational Site, Indianapolis, Indiana 46250, United States; Recruiting

Pfizer Investigational Site, Detroit, Michigan 48201, United States; Not yet recruiting

Pfizer Investigational Site, West Orange, New Jersey 07052, United States; Not yet recruiting

Pfizer Investigational Site, New York, New York 10029, United States; Recruiting

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28203, United States; Not yet recruiting

Pfizer Investigational Site, Bellevue, Ohio 44811, United States; Not yet recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States; Not yet recruiting

Pfizer Investigational Site, Johnstown, Pennsylvania 15904, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75246, United States; Not yet recruiting

Pfizer Investigational Site, Charleston, West Virginia 25301, United States; Active, not recruiting

Pfizer Investigational Site, Charleston, West Virginia 25304, United States; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: January 2007
Ending date: August 2010
Last updated: October 27, 2008