Efficacy and Safety of Itopride vs Placebo in Heartburn

A Randomized, Double-blind, Two Period, Crossover Study to Evaluate the Effects of a Single Dose of Itopride 200 mg on Esophageal and Gastric pH and Reflux in Patients With Heartburn

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00382577

Enrollment

Registered

2006-09-29

Start date

2006-10-31

Completion date

2006-12-31

Last updated

2017-02-09

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

Conditions

Heartburn

Brief summary

The purpose of this study is to evaluate the effects of itopride in patients with heartburn.

Interventions

DRUGItopride

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.

Design outcomes

Primary

Measure	Time frame
24-hour pH Monitoring	after 5 days of treatment

Countries

United States

Outcome results

None listed

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