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

Sponsored by:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00112177

Purpose

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.

Condition	Intervention	Phase
Dyspepsia	Drug: Itopride Hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Itopride

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

Symptom relief

Secondary Outcome Measures:

Impact of symptom relief on quality of life
Safety

Estimated Enrollment:	500
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2005

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112177

Locations

Canada, Quebec
Monique Giguère, Ph.D. - Programs Director
Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4

Sponsors and Collaborators

Axcan Pharma

Investigators

Principal Investigator:

Jan Tack, Professor

University Hospital Leuven

More Information

No publications provided

Study ID Numbers:	ITOFD04-03
Study First Received:	May 31, 2005
Last Updated:	January 25, 2007
ClinicalTrials.gov Identifier:	NCT00112177 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Axcan Pharma:

Functional dyspepsia
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

Additional relevant MeSH terms:

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

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on August 30, 2009