Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia - Full Text View

Sponsored by:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00110968

Purpose

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.

Condition	Intervention	Phase
Dyspepsia	Drug: Itopride hydrochloride	Phase III

MedlinePlus related topics: Indigestion

Drug Information available for: Itopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

Long-term safety

Secondary Outcome Measures:

Long-term relief of symptoms

Estimated Enrollment:	300
Study Start Date:	September 2004
Study Completion Date:	September 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110968

Sponsors and Collaborators

Axcan Pharma

Investigators

Principal Investigator:

Nicholas Talley, MD, PhD

Mayo Clinic, Rochester, Minn

More Information

Responsible Party:	Axcan Pharma inc. ( Monique Giguère )
Study ID Numbers:	ITOFD04-02
Study First Received:	May 16, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00110968
Health Authority:	United States: Food and Drug Administration

Keywords provided by Axcan Pharma:

Abdominal Symptom relief
Fullness
Bloating
Indigestion
Functional dyspepsia

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 16, 2009