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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuralgia, Spinal Cord Injuries
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Pregabalin use in the last 60 days, prior intolerance to pregabalin

- Creatinine clearance

- White blood cell count 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.

NCT00407745
Pfizer
Completed
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

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Descriptive Information
Brief Title  ICMJE A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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  ICMJE
  • Placebo Comparator: matched placebo
    Intervention: Drug: placebo
  • Experimental: pregabalin
    flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
    Intervention: Drug: pregabalin
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2011)
220
Original Enrollment  ICMJE
 (submitted: December 4, 2006)
300
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion DateFebruary 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   China,   Colombia,   Czech Republic,   Hong Kong,   India,   Japan,   Philippines,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407745
Other Study ID Numbers  ICMJE A0081107
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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