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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-002730-38 |
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The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental | TZP-101 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% dextrose in water | Drug | 60 ml IV infusion over 30 minutes |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-lead ECG data | 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal | Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Hospital | Aarhus | Denmark | ||||
| Hvidore Hospital |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| C528884 | ulimorelin |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 |
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| TZP-101 | Drug | 1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg |
|
| Copenhagen |
| Denmark |
| Karolinska University Hospital | Stockholm | Sweden |
| 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 |
| D004700 | Endocrine System Diseases |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |