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

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Week 8

Trial details

NCT IDNCT05443984

SponsorOnconic Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-05

View on ClinicalTrials.gov More Erosive Esophagitis trials