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


Tracking Information

Start Date  ICMJEJanuary 2007
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2009)
Duration Adjusted average change(DAAC)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. [ Time Frame: Daily ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: December 4, 2006)
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 15-week period.
Change HistoryComplete list of historical versions of study NCT00407745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 15, 2008)
  • Weekly mean pain score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • 30% and 50% responder rates in reduction of pain from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • The Patient Global Impression of Change score measured at treatment termination after a treatment period of up to 16 weeks [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Weekly mean sleep interference score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • The modified Brief Pain Inventory Interference Scale score changes from baseline up to 17 weeks [ Time Frame: Baseline, Week 8,12,16 ] [ Designated as safety issue: No ]
  • The Quantitative Assessment of Neuropathic Pain score changes from baseline up to 1 7 weeks [ Time Frame: Baseline and week 16 ] [ Designated as safety issue: No ]
  • Endpoint mean sleep interference score [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: Week 0 and Week 17 ] [ Designated as safety issue: No ]
  • The Hospital Anxiety and Depression Scale score changes from baseline up to 17 weeks [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • The Medical Outcomes Study Sleep Scale score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: December 4, 2006)
  • Weekly mean pain score changes from baseline up to 15 weeks
  • 30% and 50% responder rates in reduction of pain from baseline up to 15 weeks
  • Weekly mean sleep interference score changes from baseline up to 15 weeks
  • The modified Brief Pain Inventory Interference Scale score changes from baseline up to 14 weeks
  • The Medical Outcomes Study Sleep Scale score changes from baseline up to 14 weeks
  • The Hospital Anxiety and Depression Scale score changes from baseline up to 14 weeks
  • The Patient Global Impression of Change score measured at treatment termination after a treatment period of up to 14 weeks
  • The Quantitative Assessment of Neuropathic Pain score changes from baseline up to 14 weeks

Descriptive Information

Brief Title  ICMJEA 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Official Title  ICMJEA 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
Brief 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Neuralgia
  • Spinal Cord Injuries
Intervention  ICMJE
  • Drug: placebo
    Placebo
  • Drug: pregabalin
    Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
    Other Name: Lyrica
Study Arms / Comparison Groups
  • matched placebo: Placebo Comparator
    Intervention: Drug: placebo
  • pregabalin: Experimental
    flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
    Intervention: Drug: pregabalin

Recruitment Information

Estimated Enrollment  ICMJE200
Estimated Completion DateJune 2011
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Chile,   Colombia,   Czech Republic,   Hong Kong,   India,   Philippines,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00407745
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc
Study ID Numbers  ICMJEA0081107
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer