Clinical trial NCT00978341: Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Present Pain Intensity Score
timeFrame: 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 outcomes:
measure: Daily Pain Score
timeFrame: Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)
measure: Dynamic Allodynia Area
timeFrame: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,
measure: Dynamic Allodynia Pain Score
timeFrame: Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose
measure: Punctate Allodynia Area
timeFrame: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose
measure: Mechanical Pain Sensitivity Stimulus-Response Function
timeFrame: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.
measure: Pharmacokinetic Evaluations of Pregabalin
timeFrame: 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
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Warrawong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: