Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272103
Status:
COMPLETED
Last Update Posted:
2006-05-04
First Post:
2006-01-03
Brief Title:
Itopride in Functional Dyspepsiaa Dose Finding Study
Sponsor:
Royal Adelaide Hospital
Organization:
Royal Adelaide Hospital
Study Overview
Official Title:
A Multi-Centre Randomised Double-Blind Placebo-Controlled Dose Finding Study in 4 Parallel Groups to Establish the Efficacy and Safety of an Eight Week Treatment With Itopride Three Times Daily Compared to Placebo in Patients Suffering From Functional Dyspepsia
Status:
COMPLETED
Status Verified Date:
2005-11
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:
This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia
The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms
The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms
Detailed Description:
Treatment of patients with functional dyspepsia remains unsatisfactory We will assess the efficacy of Itopride a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia
Patients with functional dyspepsia will be randomized to Itopride 50 100 or 200 mg tid or placebo After 8 weeks of treatment three primary efficacy endpoints will be analyzed a change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire b patients global assessment of efficacy proportion of patients symptom-free or markedly improvedand c improvement of pain andor fullness by at least one grade on a 5-grade scale
Patients with functional dyspepsia will be randomized to Itopride 50 100 or 200 mg tid or placebo After 8 weeks of treatment three primary efficacy endpoints will be analyzed a change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire b patients global assessment of efficacy proportion of patients symptom-free or markedly improvedand c improvement of pain andor fullness by at least one grade on a 5-grade scale
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