Conditions: Spinal Cord Injuries
Keywords: Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 15
Healthy volunteers: no

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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pregabalin intervention 2: Placebo for pregabalin
Intervention descriptions: intervention 1: Pregabalin 150mg capsules BID for 7.5 days intervention 2: Placebo capsules BID for 7.5 days

Protocol document: