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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itopride Hydrochloride | Drug | 100 mg tid | ||
| itopride | Drug | 100 mg three times daily |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom relief |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of symptom relief on quality of life | ||
| Safety |
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Inclusion Criteria:
Patients suffering from functional dyspepsia according to Rome II criteria
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Talley, MD | Mayo Clinic, Rochester, Minn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AXCAN Pharma Inc. | Mont St-Hilaire | Quebec | J3H 6C4 | Canada |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C102254 | itopride |
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