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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_515 |
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The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride |
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| 2 | Experimental | sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride |
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| 3 | Experimental | sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin |
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| 4 | Experimental | sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride |
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| 5 | Experimental | sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: A: Pregabalin | Drug | 1 Pregabalin 300 mg capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| analgesic efficacy measured by patients self reported pain level after single dose administration | 5-11 hours after single dose is administered |
| Measure | Description | Time Frame |
|---|---|---|
| The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo | 24 hours after single dose is administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| 6 | Experimental | sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride |
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| Comparator: B: Duloxetine | Drug | 1 Duloxetine hydrochloride 60 mg capsule |
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| Comparator: C: Diphenhydramine hydrochloride | Drug | 1 Diphenhydramine hydrochloride 25mg capsule |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |