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
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Functional Dyspepsia Gastric Emptying Gastric Accommodation | Drug: Itopride, Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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 |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | March 2011 |
Estimated Study Completion Date : | May 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1.Itopride Group
The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
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Drug: Itopride,
Itopride,50 mg capsules,thrice a day,for Four weeks
Other Name: Gananton
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Placebo Comparator: 2.Control placebo group
The control group will receive placebo tablets for four weeks
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Drug: Placebo
placebo capsules,thrice a day for four weeks
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- 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 ]
- To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia [ Time Frame: 18 months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226134
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 |
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 |
Principal Investigator: | Shahab Abid, MD | Aga Khan University |
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 |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | October 22, 2010 |
Last Verified: | July 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 |