Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
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|ClinicalTrials.gov Identifier: NCT00112203|
Recruitment Status : Completed
First Posted : June 1, 2005
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Itopride||Phase 3|
All patients who have completed study ITOFD04-03 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)|
|Actual Enrollment :||466 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||November 2004|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||September 2006|
- Long-term safety [ Time Frame: every 2 months ]
- Long-term relief of symptoms [ Time Frame: every 2 months ]
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): NCT00112203
|Principal Investigator:||Jan Tack, MD||Leuven University|
|Principal Investigator:||Jan Tack, MD||University of Leuven|