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

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Itopride Hydrochloride
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Functional dyspepsia, Abdominal Symptom relief, Fullness, Bloating, Indigestion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Monique Giguère, Ph.D. - Programs Director

Outcomes

Primary Outcome Measures

Symptom relief

Secondary Outcome Measures

Impact of symptom relief on quality of life
Safety

Full Information

First Posted
May 31, 2005
Last Updated
February 6, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00112177
Brief Title
Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Official Title
A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Functional dyspepsia, Abdominal Symptom relief, Fullness, Bloating, Indigestion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Itopride Hydrochloride
Primary Outcome Measure Information:
Title
Symptom relief
Secondary Outcome Measure Information:
Title
Impact of symptom relief on quality of life
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Professor
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monique Giguère, Ph.D. - Programs Director
City
Mont-Saint-Hilaire
State/Province
Quebec
ZIP/Postal Code
J3H 6C4
Country
Canada

12. IPD Sharing Statement

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

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