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The study was terminated due to results in another study (NCT00878501).
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The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | 90 mg, capsules, oral, during 3 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in NRS pain (12 h-recall) | Morning and evening 12 hour recall |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline | Morning and evening 12 hour recall | |
| Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Leff, md | AstraZeneca R&D Wilmington, USA | Study Director |
| Rolf Karlsten, MD | AstraZeneca R&D Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Calgary | Alberta | Canada | |||
| Research Site |
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| Drug |
capsules, oral, during 3 weeks |
|
| Day 8, 15 and 22 |
| Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale | Day 1 and 22 |
| Halifax |
| Nova Scotia |
| Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Aalborg | Denmark |
| Research Site | Arhus C | Denmark |
| Research Site | Boulogne-Billancourt | France |
| Research Site | Clermont-Ferrand | France |
| Research Site | Nice | France |
| Research Site | Bradford | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
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