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

NCT ID: NCT01226134

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

Detailed Description

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phase3 clinical trial

Conditions

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Functional Dyspepsia Gastric Emptying Gastric Accommodation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1.Itopride Group

The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks

Group Type EXPERIMENTAL

Itopride,

Intervention Type DRUG

Itopride,50 mg capsules,thrice a day,for Four weeks

2.Control placebo group

The control group will receive placebo tablets for four weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo capsules,thrice a day for four weeks

Interventions

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Itopride,

Itopride,50 mg capsules,thrice a day,for Four weeks

Intervention Type DRUG

Placebo

placebo capsules,thrice a day for four weeks

Intervention Type DRUG

Other Intervention Names

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Gananton

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Aga Khan University,Karachi, Pakistan

Principal Investigators

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Shahab Abid, MD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Shahab Abid, MD

Role: CONTACT

[email protected]
+92 21 4864656 ext. 4656

Wasim Jafri, MD

Role: CONTACT

[email protected]
+92 21 4864659 ext. 4659

Other Identifiers

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965-Med/ERC-08

Identifier Type: -

Identifier Source: org_study_id