Efficacy and Safety of Itopride vs Placebo in Heartburn

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Heartburn

Treatments: Drug: Itopride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382577

ITOLES06-01

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind