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

Functional Dyspepsia Clinical Trial

— EIGEAPFD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01226134
• Other study ID #: 965-Med/ERC-08
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2010
• Last updated: October 21, 2010
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2010
• Source: Aga Khan University
• Contact: Shahab Abid, MD
• Phone: +92 21 4864656
• Email: shahab.abid[@]aku.edu
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

phase3 clinical trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastric Accommodation
• Gastric Emptying
• Gastritis

Intervention

Drug:
• Itopride,
Itopride,50 mg capsules,thrice a day,for Four weeks
• Placebo
placebo capsules,thrice a day for four weeks

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia		18 months	Yes
Secondary	To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia		18 months	Yes