Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: Pregabalin Drug: Placebo for pregabalin Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : February 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin Drug: Pregabalin
Pregabalin 150mg capsules BID for 7.5 days

Placebo Drug: Placebo for pregabalin
Placebo capsules BID for 7.5 days

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Dynamic Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, ]
  3. 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 ]
  4. Punctate Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose ]
  5. Mechanical Pain Sensitivity Stimulus-Response Function [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose ]
  6. Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. ]
  7. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00978341

Australia, New South Wales
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
Pfizer Investigational Site
Warrawong, New South Wales, Australia, 2502
Australia, Victoria
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00978341     History of Changes
Other Study ID Numbers: A0081141
First Posted: September 16, 2009    Key Record Dates
Results First Posted: November 9, 2009
Last Update Posted: January 12, 2010
Last Verified: January 2010

Keywords provided by Pfizer:
Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs