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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110968
• Other study ID #: ITOFD04-02
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2005
• Last updated: February 6, 2017
• Start date: September 2004
• Est. completion date: September 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Itopride hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety
Secondary	Long-term relief of symptoms