Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

February 6, 2017 updated by: Forest Laboratories

A Multicentre, Open-label Extension Phase to Study the Long-term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia

Itopride is a compound 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. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have completed the 8 week double-blind study ITOFD04-01
  • Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion Criteria:

  • Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-01 study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Long-term safety

Secondary Outcome Measures

Outcome Measure
Long-term relief of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Principal Investigator: Nicholas Talley, MD, PhD, Mayo Clinic, Rochester, Minn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

May 16, 2005

First Submitted That Met QC Criteria

May 16, 2005

First Posted (Estimate)

May 17, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITOFD04-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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