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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMAV |
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The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine hydrochloride | Drug | |||
| placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in average pain severity as measured by an 11-point Likert scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity for worst pain and night pain as measured by an 11-point Likert scale. | ||
| Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment. | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLilly (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pembroke Pines | Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17327338 | Derived | Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9. doi: 10.2337/dc06-2009. |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010146 | Pain |
| D003920 | Diabetes Mellitus |
| D059350 | Chronic Pain |
| D010523 | Peripheral Nervous System Diseases |
| C564945 | Neuropathy, Painful |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. |
| Brief Pain Inventory to measure the severity of pain. |
| Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors. |
| Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy. |
| Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus. |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 |
| Heterocyclic Compounds |