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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2010 by Aga Khan University.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Aga Khan University

ClinicalTrials.gov Identifier:

NCT01226134

First received: October 21, 2010

Last updated: NA

Last verified: July 2010

History: No changes posted

Purpose

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	Intervention
Functional Dyspepsia Gastric Emptying Gastric Accommodation	Drug: Itopride, Drug: Placebo


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

U.S. FDA Resources

Further study details as provided by Aga Khan University:

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 [ Time Frame: 18 months ]

Secondary Outcome Measures:

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


Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

phase3 clinical trial

Eligibility


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

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226134

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


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
Study First Received:	October 21, 2010
Last Updated:	October 21, 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

ClinicalTrials.gov processed this record on August 17, 2017

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