Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
|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: NCT00112177|
Recruitment Status : Completed
First Posted : June 1, 2005
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Drug: Itopride Hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
- Symptom relief
- Impact of symptom relief on quality of life
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): NCT00112177
|Monique Giguère, Ph.D. - Programs Director|
|Mont-Saint-Hilaire, Quebec, Canada, J3H 6C4|
|Principal Investigator:||Jan Tack, Professor||Universitaire Ziekenhuizen Leuven|