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

The recruitment status of this study is unknown because the information has not been verified recently.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Pakistan: Research Ethics Committee

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 May 16, 2013