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| ID | Type | Description | Link |
|---|---|---|---|
| 041026 |
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Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.
This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride.
The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Itopride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itopride | Drug | oral, three times daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying assessment | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution | weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Horowitz, M.D. | Royal Adelaide Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Adelaide, Department of Medicine | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| C102254 | itopride |
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| Other |
oral, three times daily |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |