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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. 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
Information provided by:
Aga Khan University Identifier:
First received: October 21, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

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:

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

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

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
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 identifier: NCT01226134

Contact: Shahab Abid, MD +92 21 4864656 ext 4656
Contact: Wasim Jafri, MD +92 21 4864659 ext 4659

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
Principal Investigator: Shahab Abid, MD Aga Khan University
  More Information

Responsible Party: Dr. Shahab Abid, Aga Khan University,Karachi, Pakistan 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
Gastric Emptying
Gastric Accommodation
Dyspeptic Symptoms

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases processed this record on September 21, 2017