Conditions: Neuralgia
Keywords: neuralgia postherpetic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this trial is to determine whether a novel analgesic is effective in treating of neuropathic pain caused by herpetic infection, surgery, or trauma.

Detailed description:
This trial evaluates the effectiveness of a novel analgesic in peripheral neuropathic pain in a mixed patient population. Participants were treated for one week and randomly assigned to the novel analgesic, pregabalin, or placebo. Pain will be characterized before and at the end of this period. This trial required the participants to stay at the investigational site for 14 consecutive days.

The enrollment visit took place Day -28 to Day -16. Participants tapered down their existing medication from Visit 2 (Day -17 to Day -5) to Visit 3 and were given rescue medication (paracetamol/acetaminophen). At Visit 3 participants were hospitalized (Day -4). The baseline evaluation period took place from Day -3 to Day -1. Randomization to one of the three treatment arms was possible after the last assessment on Day - 1 alternatively randomization took place on Day 1. This was followed by the double-blind treatment period (Day 1 to Day 7). The participants were follow-up thereafter up to day 36 (Day 34 to 38). Participants were permitted to resume their previous medication.

Arms:
arm 1: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen. arm 2: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen. arm 3: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.

Interventions: intervention 1: GRT6010 intervention 2: Pregabalin intervention 3: Matching Placebo
Intervention descriptions: intervention 1: Oral solution given once daily. intervention 2: Over-encapsulated pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7. intervention 3: Matching Placebo capsules to the over-encapsulated Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.

Capsules twice daily on Days 1 to 7. Solution once daily.

Protocol document: