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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01226134

Acronym

EIGEAPFD

Enrollment

Registered

2010-10-22

Start date

2009-02-28

Completion date

2011-05-31

Last updated

2010-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia, Gastric Accommodation, Gastric Emptying

Keywords

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

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

Detailed description

phase3 clinical trial

Interventions

DRUGItopride,

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

DRUGPlacebo

placebo capsules,thrice a day for four weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia	18 months

Countries

Pakistan

Contacts

Primary ContactShahab Abid, MD

shahab.abid@aku.edu+92 21 4864656

Backup ContactWasim Jafri, MD

wasim.jafri@aku.edu+92 21 4864659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026