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Completed

NCT Number: NCT05842408

Clinical Trial of DA-5212 in Patients with Functional Dyspepsia

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

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Key information

Conditions

Functional Dyspepsia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wonkwang University Hospital

Iksan, Muwangro 895, 54538, South Korea

Who can participate

Healthy volunteers accepted: No

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

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 upper gastrointestinal endoscopy at screening visit

Exclusion criteria

  • Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
  • Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
  • Patients with hypersensitivity to investigational drugs and similar drugs
  • Pregnant or breastfeeding women

Treatment and study plan

DA-5212

Drug

Test drug: DA-5212

DA-5212-R

Drug

Control drug: DA-5212-R

Primary outcomes

  1. Change in NDI-K functional dyspepsia score

    Time frame: Change from baseline at 4 weeks

Secondary outcomes

  1. Change in overall treatment score of patients

    Time frame: Change from baseline at 4 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Dec 13, 2024

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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