Neuralgia Clinical Trial
Official title:
Evaluation of the Efficacy, Tolerability, and Safety of 7 Days of Treatment With GRT6010 or Pregabalin in Comparison to Placebo in Subjects With Peripheral Neuropathic Pain.
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.
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.
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