CompletedPhase 3

JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis

South Korea300 participantsStarted 2022-01-17

Plain-language summary

To evaluate the efficacy and safety of JP-1366 20 mg compared to esomeprazole 40 mg in patients with erosive esophagitis

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female, ≥ 19 years of age at the time of obtaining consent
✓. Subjects who had experienced heartburn and regurgitation within 7 days prior to the screening visit, those whose severity and frequency of symptoms fall under the following (1) or (2)
✓. Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization
✓. Subjects who fully understand this study and voluntarily signed on the informed consent form

✕. Subjects who can't undergo endoscopy
✕. Medical History
✕. Laboratory Test
✕. Allergy and drug hypersensitivity
✕. Prohibited medication and therapy
✕. Pregnant and lactating women
✕. Contraception Subjects who do not agree to use medically acceptable methods of contraception during the period study
✕. Subjects with clinically significant psychiatric disorder and a history with a drug and alcohol abuse.

The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)

Timeframe: Week 8

NCT IDNCT05443984

SponsorOnconic Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-05