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

October 21, 2010 updated by: Aga Khan University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

phase3 clinical trial

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Shahab Abid, MD, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

October 22, 2010

Last Update Submitted That Met QC Criteria

October 21, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 965-Med/ERC-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Dyspepsia

Clinical Trials on Itopride,

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe