Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study Full Text
Journal of Pain Research, 07/31/2012
Jenkins TM et al. – The efficacy of pregabalin was similar to that identified in a large, parallel group trial in post–traumatic peripheral neuropathic pain (PTNP). Therefore, this efficient crossover study design has potential utility for future proof–of–concept studies in neuropathic pain.Methods
- Authors designed a proof–of–concept, double–blind, randomized, placebo–controlled, crossover study in patients with post–traumatic peripheral neuropathic pain (PTNP) to evaluate whether such a study design had the potential to detect efficacious agents.
- Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic.
- They also assessed physical activity throughout the study.
- Twenty–five adults (20–70 years of age) with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences:
- Pregabalin followed by placebo.
- Or placebo followed by pregabalin.
- These 2–week treatment periods were separated by a 2–week washout period.
- Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15).
- In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2–week washout period.
- Average daily pain scores (primary endpoint) were significantly reduced for pregabalin versus placebo, with a mean treatment difference of –0.81 (95% confidence interval: –1.45 to –0.17; P = 0.015).