Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

Last updated: December 10, 2024
Sponsor: Dong-A ST Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Stomach Discomfort

Gastroparesis

Colic

Treatment

DA-5212

DA-5212-R

Clinical Study ID

NCT05842408
DA5212_FDQ_III
  • Ages > 19
  • All Genders

Study Summary

This study is to evaluate efficacy and safety of DA-5212 in patients with functional dyspepsia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women ≥ 19 years of age

  • Patients who diagnosed with functional dyspepsia

  • Patients with no organic cause for digestive symptoms found by uppergastrointestinal endoscopy at screening visit

Exclusion

Exclusion Criteria:

  • Patients with organic disease or medical history that may cause dyspepsia within 6months before screening visit

  • Patients who have a history of drugs or alcohol abuse and dependence within 6 monthsbefore screening visit

  • Patients with hypersensitivity to investigational drugs and similar drugs

  • Pregnant or breastfeeding women

Study Design

Total Participants: 384
Treatment Group(s): 2
Primary Treatment: DA-5212
Phase: 3
Study Start date:
June 06, 2023
Estimated Completion Date:
September 04, 2024

Connect with a study center

  • Wonkwang University Hospital

    Iksan, Muwangro 895 54538
    Korea, Republic of

    Site Not Available

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