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

Aga Khan University

Status: Unknown

Conditions: Gastric Emptying; Functional Dyspepsia; Gastric Accommodation

Treatments: Drug: Placebo; Drug: Itopride,

Study type: Interventional

Funder types: Other

Identifiers

NCT01226134

965-Med/ERC-08

Details and patient eligibility

About

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

Full description

phase3 clinical trial

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

1.Itopride Group

Experimental group

Description:

The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks

Treatment:

Drug: Itopride,

2.Control placebo group

Placebo Comparator group

Description:

The control group will receive placebo tablets for four weeks

Treatment:

Drug: Placebo