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

Study Description

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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	Not Applicable

Detailed Description:

phase3 clinical trial

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	February 2009
Estimated Primary Completion Date :	March 2011
Estimated Study Completion Date :	May 2011

Arms and Interventions

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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 Name: 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

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Primary Outcome Measures :

1. To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia [ Time Frame: 18 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Shahab Abid, MD	+92 21 4864656 ext 4656	shahab.abid@aku.edu
Contact: Wasim Jafri, MD	+92 21 4864659 ext 4659	wasim.jafri@aku.edu

Locations

Pakistan
Aga Khan University	Recruiting
Karachi, Sindh, Pakistan, 74800
Principal Investigator: Shahab Abid, MD
Sub-Investigator: Wasim Jafri, MD
Sub-Investigator: Maseeh Uzzaman, MD
Sub-Investigator: Rakhshanda Bilal
Sub-Investigator: Soobia Siddiqui, MD
Sub-Investigator: Greger Lindberg, MD,PhD

Sponsors and Collaborators

Aga Khan University

Investigators

Principal Investigator:	Shahab Abid, MD	Aga Khan University

More Information

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Responsible Party:	Dr. Shahab Abid, Aga Khan University,Karachi, Pakistan
ClinicalTrials.gov Identifier:	NCT01226134 History of Changes
Other Study ID Numbers:	965-Med/ERC-08
First Posted:	October 22, 2010
Last Update Posted:	October 22, 2010
Last Verified:	July 2010

Keywords provided by Aga Khan University:

Functional Dyspepsia; Itopride; Gastric Emptying; Gastric Accommodation; Dyspeptic Symptoms

Additional relevant MeSH terms:

Dyspepsia; Gastritis; Signs and Symptoms, Digestive; Signs and Symptoms	Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases