Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
Phase 2
Completed
- Conditions
- Postherpetic Neuralgia
- Interventions
- Registration Number
- NCT01106716
- Lead Sponsor
- KAI Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- pain score at least 4 on 11-point numerical rating scale (0-10)
- stable doses of analgesic medications for at least 1 month"
Exclusion Criteria
- diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- pain score at least 4 on 11-point numerical rating scale (0-10)
- stable doses of analgesic medications for at least 1 month"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A1: Placebo Placebo Placebo A2: KAI-1678 KAI-1678 Experimental A3: Lidocaine Lidocaine Lidocaine
- Primary Outcome Measures
Name Time Method The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). Day 1 Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.
- Secondary Outcome Measures
Name Time Method The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours Day 1 The effect of KAI-1678 on patient global response to treatment Day 1 The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS) Day 1 The number of adverse events as a measure of safety and tolerability of KAI-1678 Two weeks Frequency of adverse events on each study treatment