Postherpetic Neuralgia
Conditions
Keywords
Lidocaine, Lignocaine, Analgesics. Non-narcotic / therapeutic use, Neuralgia, Postherpetic, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy, PHN
Brief summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
Interventions
Sponsors
Trident Clinical Research Pty Ltd
KAI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Outcome results
None listed