Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370084
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2006-08-28
Brief Title:
Itopride Hydrochloride in Diabetes Effects on Gastric Emptying and Glycemia
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Effects of Itopride Hydrochloride on Gastric Emptying Glycaemia and Meal-related Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 041026 | None | None | None |