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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022557-42 | EudraCT Number |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 µg GRT6005 | Active Comparator | Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day |
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| 75 µg GRT6005 | Active Comparator | Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day |
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| 200 µg GRT6005 | Active Comparator | Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day |
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| Matching Placebo | Placebo Comparator | Participants allocated to this treatment arm will receive a dose of matched placebo once a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRT6005 | Drug | 25µg/day once daily |
| |
| GRT6005 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean daily pain intensity score | Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine". | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Response measured in percentage change of pain intensity from baseline | End of 4 Weeks | |
| Changes in Quantitative Sensory Testing from baseline | Baseline, week 1 and week 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Forst, Prof. Dr. | ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 4502 | Sofia | 1431 | Bulgaria | |||
| Site 4112 |
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| Drug |
75 µg/day once daily |
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| GRT6005 | Drug | 200 µg/day once daily |
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| Matching Placebo | Drug | Once daily |
|
| Neuropathic Pain Scale, changes from baseline |
| End of 4 weeks |
| Short Form of the Brief Pain Inventory, changes from baseline | End of 4 weeks |
| Leeds Sleep Evaluation Questionnaire | End of treatment |
| Quality of Life Index -Short-Form-12®, from baseline | End of treatment |
| Patient's Global Impression of Change | End of treatment |
| Quality of Life EuroQoL-5 Dimension score, change from baseline | End of 4 weeks |
| Rescue medication use | End of 4 weeks |
| Clinical Opioid Withdrawal Scale | End of 4 weeks |
| Plasma concentration | End of 4 weeks |
| Aschaffenburg |
| 63739 |
| Germany |
| Site 4109 | Bad Oeynhausen | 32545 | Germany |
| Site 4101 | Berlin | 10117 | Germany |
| Site 4110 | Berlin | 13125 | Germany |
| Site 4111 | Dresden | 01307 | Germany |
| Site 4107 | Hamburg | 20253 | Germany |
| Site 4117 | Hamburg | 22587 | Germany |
| Site 4108 | Hanover | 30159 | Germany |
| Site 4104 | Hanover | 30167 | Germany |
| Site 4115 | Heidelberg | 69120 | Germany |
| Site 4106 | Kiel | 24119 | Germany |
| Site 4102 | Lübeck | 23562 | Germany |
| Site 4103 | Mainz | 55116 | Germany |
| Site 4105 | Münster | 48145 | Germany |
| Site 4113 | Schwerin | 19055 | Germany |
| Site 4116 | Wangen | 88239 | Germany |
| Site 4405 | Bucharest | 010496 | Romania |
| Site 4402 | Bucharest | 011025 | Romania |
| Site 4407 | Sibiu | 550166 | Romania |
| Site 4401 | Târgu Mureş | 540139 | Romania |
| Site 4406 | Timișoara | 300594 | Romania |
| ID | Term |
|---|---|
| D010146 | Pain |
| D003929 | Diabetic Neuropathies |
| D000377 | Agnosia |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| 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 |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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