NCT07686679

Brief Summary

This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
14mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Oct 2027

First Submitted

Initial submission to the registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Changes in GIS(Gastrointestinal Symptom Score) total scores

    Change from baseline at 4 weeks

Secondary Outcomes (5)

  • Changes in GIS(Gastrointestinal Symptom Score) total scores

    Change from baseline at 2 weeks

  • Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms

    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

    Change from baseline at 4 weeks

  • Subject's global assessment

    at week 4

  • Investigator's global assessment

    at week 4

Study Arms (2)

DA-9701

EXPERIMENTAL

administered for 4weeks(DA-9701 + DA-9701-R placebo)

Drug: DA-9701Drug: DA-9701-R Placebo

DA-9701-R

ACTIVE COMPARATOR

administered for 4weeks(DA-9701-R + DA-9701 placebo)

Drug: DA-9701-RDrug: DA-9701 Placebo

Interventions

DA-9701DRUG

1 tablet, TID

DA-9701
DA-9701-RDRUG

1 tablet, TID

DA-9701-R
DA-9701 PlaceboDRUG

1 tablet, TID

DA-9701-R
DA-9701-R PlaceboDRUG

1 tablet, TID

DA-9701

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with a history of organic diseases that could cause dyspepsia
  • Subjects with hypersensitivity to investigational drugs and similar drugs
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DA-9701

Central Study Contacts

Sang Kil Lee

CONTACT

+82) 02-2228-4000SKLEE@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share