CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 262 enrolled
Drug / intervention
Omeprazole +3 moredrug
Likely dose
Omeprazole 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01851863
NCT01851863Phase 4Completed
CompareCT.gov

Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors

RenJi Hospital·interventional·Posted May 13, 2013·Updated Feb 23, 2015

In Brief

A Phase 4 clinical trial evaluating Omeprazole, Flupentixol-Melitracen(psychological and GI) + Omeprazole, and 2 other interventions for Dyspepsia and 2 related conditions. Completed, enrolled 262 participants across 1 site.

Detailed Summary

The study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of FD symptoms and the drugs' effects might improve compliance with psychoactive agent regimens among FD patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspepsia, Compliance, Depression
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 13, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.1 years ago

Interventions

Omeprazoledrug

Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).

Flupentixol-Melitracen(psychological and GI) + Omeprazoledrug

Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.

Flupentixol-Melitracen(psychological) + Omeprazoledrug

Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.

Flupentixol-Melitracen(without explanation) + Omeprazoledrug

Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.