A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia
ConditionFunctional Dyspepsia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-75
SponsorDong-A ST Co., Ltd.
About this trial
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged 19 to 75 years, inclusive
Subjects diagnosed with functional dyspepsia according to the Rome IV criteria
Subjects with at least three symptoms rated as moderate or severe on the Gastrointestinal Symptom Score(GIS)
Subjects who voluntarily signed a consent form
Disqualifiers
Subjects with a history of organic diseases that could cause dyspepsia
Subjects with hypersensitivity to investigational drugs and similar drugs
Pregnant or breastfeeding women
Trial design
Design model
Parallel
Treatments tested in this trial
DA-9701
Drug1 tablet, TID
DA-9701-R
Drug1 tablet, TID
DA-9701 Placebo
Drug1 tablet, TID
DA-9701-R Placebo
Drug1 tablet, TID
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: DA-9701Experimental treatment 2 interventions
Group B: DA-9701-RActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time frame
Change from baseline at 4 weeksSecondary outcomes
1
Changes in GIS(Gastrointestinal Symptom Score) total scores
Time frame
Change from baseline at 2 weeks2
Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms
Time frame
Change from baseline at 2 weeks and 4 weeks3
Changes in NDI-K QoL(Nepean Dyspepsia Index-Korean version Quality of Life) domain scores and total scores
Time frame
Change from baseline at 4 weeks4
Subject's global assessment
Time frame
at week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov