Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia

Not Applicable

• Conditions: Gastric Accommodation; Functional Dyspepsia; Gastric Emptying
• Interventions: Drug: Placebo; Drug: Itopride,

• Registration Number: NCT01226134
• Lead Sponsor: Aga Khan University

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 Timeline

• Study Start: 2009-02
• Status Verified: 2010-07
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Last Update Submitted: 2010-10-21
• Study First Posted: 2010-10-22
• Last Update Posted: 2010-10-22
• Primary Completion: 2011-03
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered
2. Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.
3. duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology
4. A normal upper abdominal ultrasound
5. Willing to participate and give consent for participation in the study.

Exclusion Criteria

1. Age <18 years

2. Helicobacter Pylori positive on gastric biopsy and / or UBT.

3. Taking other medications that alter gastric motility like macrolide

   • anti-emetics and antibiotics .

4. Pregnant or breast-feeding females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.Control placebo group	Placebo	The control group will receive placebo tablets for four weeks
1.Itopride Group	Itopride,	The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks

Primary Outcome Measures

Name	Time	Method
To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia	18 months

Secondary Outcome Measures

Name	Time	Method
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia	18 months

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan