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

Study Overview
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Brief Summary
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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
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phase3 clinical trial

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

Conditions
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Functional Dyspepsia, Gastric Emptying, Gastric Accommodation

Intervention / Treatment
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* Drug: Itopride,
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test. duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology A normal upper abdominal ultrasound Willing to participate and give consent for participation in the study. Exclusion Criteria: Age <18 years Helicobacter Pylori positive on gastric biopsy and / or UBT. Taking other medications that alter gastric motility like macrolide anti-emetics and antibiotics . Pregnant or breast-feeding females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.Itopride Group<br>The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks | Drug: Itopride,<br>* Itopride,50 mg capsules,thrice a day,for Four weeks<br>* Other names: Gananton;|
| Placebo Comparator: 2.Control placebo group<br>The control group will receive placebo tablets for four weeks | Drug: Placebo<br>* placebo capsules,thrice a day for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, Itopride, Gastric Emptying, Gastric Accommodation, Dyspeptic Symptoms