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

NCT01226134 | Unknown

• 1 other identifier: 965-Med/ERC-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Functional Dyspepsia; Gastric Emptying; Gastric Accommodation

Keywords

Functional Dyspepsia; Itopride; Gastric Emptying; Gastric Accommodation; Dyspeptic Symptoms

Outcome Measures

Primary Outcomes (1)

• To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia

  18 months

Secondary Outcomes (1)

• To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia

  18 months

Study Arms (2)

1.Itopride Group

EXPERIMENTAL

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

Drug: Itopride,

2.Control placebo group

PLACEBO COMPARATOR

The control group will receive placebo tablets for four weeks

Drug: Placebo

Interventions

Itopride, DRUG

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

Also known as: Gananton

1.Itopride Group

Placebo DRUG

placebo capsules,thrice a day for four weeks

2.Control placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Interventions

itopride

Study Officials

• Shahab Abid, MD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahab Abid, MD

CONTACT

+92 21 4864656; shahab.abid@aku.edu

Wasim Jafri, MD

CONTACT

+92 21 4864659; wasim.jafri@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 22, 2010

Record last verified: 2010-07

Locations

PA (1)