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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

itopride

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

AXCAN Pharma Inc.

Outcomes

Primary Outcome Measures

Symptom relief

Secondary Outcome Measures

Impact of symptom relief on quality of life

Safety

Full Information

NCT ID

NCT00112190

First Posted

May 31, 2005

Last Updated

February 6, 2017

Sponsor

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00112190

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

March 2005 (Actual)

Study Completion Date

March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Forest Laboratories

4. Oversight

Data Monitoring Committee

Yes

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

645 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Itopride Hydrochloride

Intervention Description

100 mg tid

Intervention Type

Drug

Intervention Name(s)

itopride

Intervention Description

100 mg three times daily

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

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Talley, MD

Organizational Affiliation

Mayo Clinic, Rochester, Minn

Official's Role

Principal Investigator

Facility Information:

Facility Name

AXCAN Pharma Inc.

City

Mont St-Hilaire

State/Province

Quebec

ZIP/Postal Code

J3H 6C4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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