Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
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|ClinicalTrials.gov Identifier: NCT00110968|
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : February 8, 2017
|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|
|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 :||September 2004|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||September 2006|
- Long-term safety
- Long-term relief of symptoms
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|