Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112190
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2005-05-31
Brief Title:
Effect of Itopride on Symptoms of Functional Dyspepsia Such as Indigestion Bloating Inability to Finish a Meal
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
A Multicentre Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None