drugset / Trial / NCT02336555

The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)

NCT02336555 ↗

Phase 1 Completed 35 enrolled Merck Sharp & Dohme LLC
RandomizedCrossoverDouble-blindTreatment

Summary

This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia. The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.

Timeline

Start
2015-03-12
Primary completion
2016-02-29
Completion
2016-02-29

Outcome

Missed primary endpoint

registry analysis (superiority test); MK-8291 vs Placebo; p = 0.075; Mean Difference (Final Values) -0.452 (95% CI -1.076 to 0.172) NCT02336555 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8291 Unknown 10 mg Oral