Viewing Study NCT01226134


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Study NCT ID: NCT01226134
Status: UNKNOWN
Last Update Posted: 2010-10-22
First Post: 2010-10-21
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Sponsor: Aga Khan University
Organization:

Study Overview

Official Title: Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Status: UNKNOWN
Status Verified Date: 2010-07
Last Known Status: RECRUITING
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: EIGEAPFD
Brief Summary: Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.

Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.

Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.

This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients
Detailed Description: phase3 clinical trial

Study Oversight

Has Oversight DMC: False
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?: