A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DA-9701, DA-9701-R, DA-9701 Placebo, DA-9701-R Placebo.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia
Overview
This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia
Interventions
- Drug DA-9701
1 tablet, TID - Drug DA-9701-R
1 tablet, TID - Drug DA-9701 Placebo
1 tablet, TID - Drug DA-9701-R Placebo
1 tablet, TID
Primary outcome measures
- Changes in GIS(Gastrointestinal Symptom Score) total scores [Time frame: Change from baseline at 4 weeks]
Secondary outcome measures (5)
- Changes in GIS(Gastrointestinal Symptom Score) total scores [Time frame: Change from baseline at 2 weeks]
- Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms [Time frame: Change from baseline at 2 weeks and 4 weeks]
- 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 weeks]
- Subject's global assessment [Time frame: at week 4]
- Investigator's global assessment [Time frame: at week 4]
Eligibility criteria
Main Inclusion Criteria:
- 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
Main Exclusion Criteria:
- Subjects with a history of organic diseases that could cause dyspepsia
- Subjects with hypersensitivity to investigational drugs and similar drugs
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07686679 · DA9701_FD_IV