Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00110968 |
Recruitment Status :
Completed
First Posted : May 17, 2005
Last Update Posted : February 8, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyspepsia | Drug: Itopride hydrochloride | Phase 3 |
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 (Clinical Trial) |
Enrollment : | 300 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | July 2006 |
Actual Study Completion Date : | September 2006 |
- Long-term safety
- Long-term relief of symptoms

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110968
Principal Investigator: | Nicholas Talley, MD, PhD | Mayo Clinic, Rochester, Minn |
Responsible Party: | Monique Giguère, Axcan Pharma inc. |
ClinicalTrials.gov Identifier: | NCT00110968 |
Other Study ID Numbers: |
ITOFD04-02 |
First Posted: | May 17, 2005 Key Record Dates |
Last Update Posted: | February 8, 2017 |
Last Verified: | February 2017 |
Abdominal Symptom relief Fullness Bloating Indigestion Functional dyspepsia |
Dyspepsia Signs and Symptoms, Digestive |