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Trial record 1 of 1 for:    NCT00978341
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Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

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ClinicalTrials.gov Identifier: NCT00978341
Recruitment Status : Terminated (See Detailed Description)
First Posted : September 16, 2009
Results First Posted : November 9, 2009
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 15, 2009
First Posted Date  ICMJE September 16, 2009
Results First Submitted Date  ICMJE September 28, 2009
Results First Posted Date  ICMJE November 9, 2009
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
Present Pain Intensity Score [ Time Frame: Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
To assess the effect of pregabalin, following a single oral dose and at steady-state, on present pain intensity score in patients with neuropathic pain as a result of spinal cord injury. [ Time Frame: 7.5 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
  • Daily Pain Score [ Time Frame: Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2) ]
  • Dynamic Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, ]
  • Dynamic Allodynia Pain Score [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose ]
  • Punctate Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose ]
  • Mechanical Pain Sensitivity Stimulus-Response Function [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. ]
  • Pharmacokinetic Evaluations of Pregabalin [ Time Frame: Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • To assess the effect of pregabalin on the daily pain score, area and pain score for evoked dynamic brush allodynia, mechanical pain sensitivity stimulus response function, and punctate allodynia area. [ Time Frame: 7.5 days ]
  • To assess the effect of pregabalin on the Neuropathic Pain Symptom Inventory (NPSI) questionnaire. [ Time Frame: 7.5 days ]
  • To collect plasma samples to allow modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships. [ Time Frame: 7.5 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
Official Title  ICMJE A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound
Brief Summary The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.
Detailed Description This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Drug: Pregabalin
    Pregabalin 150mg capsules BID for 7.5 days
  • Drug: Placebo for pregabalin
    Placebo capsules BID for 7.5 days
Study Arms  ICMJE
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo
    Intervention: Drug: Placebo for pregabalin
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 15, 2009)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • subjects who are outpatients or inpatients
  • written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
  • traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
  • At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
  • Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury

Exclusion Criteria:

  • spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
  • subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978341
Other Study ID Numbers  ICMJE A0081141
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP