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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00978341
First received: September 15, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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 Intervention
Spinal Cord Injuries
Drug: Pregabalin
Drug: Placebo for pregabalin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Dynamic Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Punctate Allodynia Area [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose ] [ Designated as safety issue: No ]
  • Mechanical Pain Sensitivity Stimulus-Response Function [ Time Frame: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: Pregabalin
Pregabalin 150mg capsules BID for 7.5 days
Placebo Drug: Placebo for pregabalin
Placebo capsules BID for 7.5 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978341

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00978341     History of Changes
Other Study ID Numbers: A0081141
Study First Received: September 15, 2009
Results First Received: September 28, 2009
Last Updated: January 6, 2010
Health Authority: Australian: Department of Health and Ageing Therapeutic Goods Administration

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
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 21, 2014