Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori

PHASE3RecruitingINTERVENTIONAL
Enrollment

460

Participants

Timeline

Start Date

February 6, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

June 30, 2026

Conditions
Helicobacter Pylori InfectionHelicobacter Pylori Infected PatientsHelicobacter Pylori Infected Subjects
Interventions
DRUG

DWP14012 40mg

DWP14012 40 mg, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).

DRUG

DWC202301 30mg

DWC202301 30 mg, capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).

DRUG

Amoxicillin 1000mg

Amoxicillin 1000 mg(2 capsules of 500mg), capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).

DRUG

Clarithromycin 500mg

Clarithromycin 500 mg, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)

DRUG

DWC202301 30mg placebo

DWC202301 30 mg placebo, capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)

DRUG

DWP14012 40mg placebo

DWP14012 40 mg placebo, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)

Trial Locations (1)

Unknown

RECRUITING

Asan Medical Center, Seoul

All Listed Sponsors
collaborator

iNtherapeutics Co. LTD

UNKNOWN

lead

Daewoong Pharmaceutical Co. LTD.

INDUSTRY