Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal

Forest Laboratories

Status and phase

Completed

Phase 3

Conditions

Dyspepsia

Treatments

Drug: itopride

Drug: Itopride Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00112190

ITOFD04-01

Details and patient eligibility

About

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Full description

The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Enrollment

645 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients suffering from functional dyspepsia according to Rome II criteria
- 18-65 years old
- Absence of, or infrequent heartburn (one episode per week or less)
- Helicobacter pylori (H. pylori) negative
- Normal upper endoscopy