This trial is active, not recruiting.

Condition dyspepsia
Treatment itopride hydrochloride
Phase phase 3
Sponsor Axcan Pharma
Start date July 2004
End date December 2005
Trial size 500 participants
Trial identifier NCT00112177, ITOFD04-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Symptom relief
time frame:

Secondary Outcomes

Impact of symptom relief on quality of life
time frame:
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Principal investigator Jan Tack, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Axcan Pharma.