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

Dyspepsia Clinical Trial

Official title:

A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112177
• Other study ID #: ITOFD04-03
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2005
• Last updated: February 6, 2017
• Start date: July 2004
• Est. completion date: August 2006

Study information

• Verified date: February 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Itopride Hydrochloride

Locations

Country	Name	City	State
Canada	Monique Giguère, Ph.D. - Programs Director	Mont-Saint-Hilaire	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom relief
Secondary	Impact of symptom relief on quality of life
Secondary	Safety