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

Sponsor

Aga Khan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01226134

Collaborator

(none)

Enrollment

Location

Arms

26.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Gastric Emptying Gastric Accommodation	Drug: Itopride, Drug: Placebo	N/A

Detailed Description

phase3 clinical trial

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2011

Anticipated Study Completion Date :

May 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1.Itopride Group

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

Drug: Itopride,

Itopride,50 mg capsules,thrice a day,for Four weeks

Other Names:

Gananton

Placebo Comparator: 2.Control placebo group

The control group will receive placebo tablets for four weeks

Drug: Placebo

placebo capsules,thrice a day for four weeks

Outcome Measures

Primary Outcome Measures

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

To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.