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

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ClinicalTrials.gov Identifier: NCT01226134
Recruitment Status : Unknown
Verified July 2010 by Aga Khan University.
Recruitment status was:  Recruiting
First Posted : October 22, 2010
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Aga Khan University

October 21, 2010
October 22, 2010
October 22, 2010
February 2009
March 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia

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

phase3 clinical trial
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Functional Dyspepsia
  • Gastric Emptying
  • Gastric Accommodation
  • Drug: Itopride,
    Itopride,50 mg capsules,thrice a day,for Four weeks
    Other Name: Gananton
  • Drug: Placebo
    placebo capsules,thrice a day for four weeks
  • Experimental: 1.Itopride Group
    The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
    Intervention: Drug: Itopride,
  • Placebo Comparator: 2.Control placebo group
    The control group will receive placebo tablets for four weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
May 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
 
NCT01226134
965-Med/ERC-08
No
Not Provided
Not Provided
Dr. Shahab Abid, Aga Khan University,Karachi, Pakistan
Aga Khan University
Not Provided
Principal Investigator: Shahab Abid, MD Aga Khan University
Aga Khan University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP