Conditions: Postherpetic Neuralgia
Keywords: pain delta opioid receptor agonist
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 41
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.

Detailed description:

Arms:
arm 1: ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. arm 2: Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.

Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. arm 3: Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.

Interventions: intervention 1: ADL5747 intervention 2: Placebo intervention 3: Pregabalin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: