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NCT Number: NCT07686679

A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia

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

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Key information

Conditions

Functional Dyspepsia

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-9701

Drug

1 tablet, TID

DA-9701-R

Drug

1 tablet, TID

DA-9701 placebo

Drug

1 tablet, TID

DA-9701-R Placebo

Drug

1 tablet, TID

Primary outcomes

  1. Changes in GIS(Gastrointestinal Symptom Score) total scores

    Time frame: Change from baseline at 4 weeks

Secondary outcomes

  1. Changes in GIS(Gastrointestinal Symptom Score) total scores

    Time frame: Change from baseline at 2 weeks

  2. Changes in GIS(Gastrointestinal Symptom Score) scores by symptoms

    Time frame: Change from baseline at 2 weeks and 4 weeks

  3. 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

  4. Subject's global assessment

    Time frame: at week 4

  5. Investigator's global assessment

    Time frame: at week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Kil Lee

CONTACT

[email protected]

+82) 02-2228-4000

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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