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| Name | Class |
|---|---|
| Trident Clinical Research Pty Ltd | INDUSTRY |
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The purpose of this study is to determine whether KAI-1678 is effective in the treatment of postherpetic neuralgia pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1: Placebo | Placebo Comparator | Placebo |
|
| A2: KAI-1678 | Experimental | Experimental |
|
| A3: Lidocaine | Active Comparator | Lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo IV Infusion |
| |
| KAI-1678 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). | Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Bell, MD | KAI Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney | New South Wales | Australia |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C584124 | KAI-1678 |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
KAI-1678 IV Infusion |
|
| Lidocaine | Drug | Lidocaine |
|
| 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 | Frequency of adverse events on each study treatment | Two weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |