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Erosive EsophagitisPhase 3NCT05443984

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

A Phase 3 study testing JP-1366 20mg and Esomeprazole 40mg in people with Erosive Esophagitis, run by Onconic Therapeutics Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Erosive Esophagitis
What is being tested?
JP-1366 20mg and Esomeprazole 40mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSouth Korea
Study dates
17 Jan 2022to 5 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • Inclusion Criteria: Subjects must satisfy all the following criteria.
  1. Male or female, ≥ 19 years of age at the time of obtaining consent
  2. 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) ⑴ Subjects who have experienced mild or more severe heartburn or regurgitation at least twice a week ⑵ Subjects who have experienced moderate or more severe heartburn or regurgitation at least once a week
  3. Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization
  4. Subjects who fully understand this study and voluntarily signed on the informed consent form
  • Exclusion Criteria: Subjects may not satisfy any of the following criteria.
  1. Subjects who can't undergo endoscopy
  2. Medical History º Subjects who have warning symptoms of the malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (except negative result for malignancy by endoscopy) º Subjects with eosinophilic esophagitis (except negative result by esophageal biopsy) º Subjects who have esophageal stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumor confirmed by EGD º Zollinger-Ellison syndrome patients º Subjects diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected with IBS in the last 3 months and with a current history of the disease including pancreatitis º Subjects who have a history of gastric acid suppression surgery, gastrointestinal or esophageal surgery (except appendectomy, cholecystectomy, polypectomy) º Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, urinary, neuro-psychiatric, hemato-oncologic disorder º Subjects who have a history of malignant tumor in 5 years at the time of screening. However, excluding subjects with malignant gastrointestinal cancer regardless of the period.
  3. Laboratory Test Screening laboratory test showing any of the following abnormal laboratory results: º ALT or AST > 2.0 x ULN º ALP or GGT > 2.0 x ULN º Total bilirubin > 2.0 x ULN º eGFR<70 mL/min/1.73 m2 (CKD-EPI formula) º Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test) º Clinically significant ECG abnormalities
  4. Allergy and drug hypersensitivity º Known hypersensitivity to the active ingredient or excipients of the investigational product º Clinically significant allergies (except mild allergic rhinitis) or hypersensitivity history to drugs. (Aspirin, antibiotics, etc.)
  5. Prohibited medication and therapy º Subjects who take gastric acid suppressant like P-CAB, PPI within 2weeks prior to EGD of screening procedure º Subjects who take medication (antacids, prokinetics, H2RA, etc.) related to reflux esophagitis more than 2times within 1week prior to EGD of screening procedure º Subjects who need to take medication (aspirin, NSAIDs, etc.) that may cause an ulcer, during the study period º Subjects who are on or need to be on the medications which categorized as contraindicated in this clinical trial. However, subjects who are on the contraindicated medications can participate in the trial after the washout period of 2 weeks. If five times of the half-life of the contraindicated medications exceeds 2 weeks, the washout period will be set as five times of the half-life.
  6. Pregnant and lactating women
  7. Contraception Subjects who do not agree to use medically acceptable methods of contraception during the period study
  8. Subjects with clinically significant psychiatric disorder and a history with a drug and alcohol abuse.
  9. Subjects who are judged unsuitable to participate in the study in the opinion of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center and 26 hospitals

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Parallel, Active-controlled, Non-inferiority, Phase III Multiple Center Clinical Trial to Compare the Efficacy and Safety of JP-1366 20 mg Versus Esomeprazole 40 mg in Patients With Erosive Esophagitis

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

Being tested
JP-1366 20mg, Esomeprazole 40mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JP-1366 20mgDrug

    1 capsule of JP-1366 20 mg, 1 tablet of esomeprazole placebo (irrespective of meals)

  • Esomeprazole 40mgDrug

    1 capsule of JP-1366 placebo, 1 tablet of esomeprazole 40 mg placebo (irrespective of meals)

Study groups in NCT05443984
Study groupRoleWhat they receive
Experimental GroupExperimentalJP-1366 20mg + Esomeprazole 40mg(placebo)
Receives: Drug: JP-1366 20mg
Active Comparative GroupActive comparatorJP-1366 20mg(placebo) + Esomeprazole 40mg
Receives: Drug: Esomeprazole 40mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The proportion of subjects with remission on endoscopy at 8-week

    Measured: Week 8

Secondary outcomes (6)

  1. Healing rate of mucosal break at the 4-week after the investigational product administration

    The proportion of subjects whose mucosal breaks are healed on the 4-week endoscopy

    Measured: Week 4

  2. Healing rate of mucosal break evaluated by an independent evaluator at the 4-week after the investigational product administration

    Measured: Week 4

  3. The cumulative Healing rate of mucosal break evaluated by an independent evaluator at the 8-week after the investigational product administration

    Measured: Week 8

  4. Symptom assessment according to the RDQ questionnaire

    Measured: Week 4 and 8

  5. Gastro-esophageal symptoms assessment through subject diary at 4, 8 weeks

    Measured: within 24hours after IP administration, during 7days after IP administration, Week 4 and 8

  6. Change from baseline in the total score of GERD-HRQL at 4, 8-week and cumulative changes in quality of life at 8week

    Measured: Week 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start17 Jan 2022
  3. Primary completion5 Jan 2023
  4. Study completion5 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443984
Sponsor's protocol ID
JP-1366-301
Status last verified
Jul 2022
First submitted
28 Jun 2022
Last updated
27 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oh JH, Kim HS, Cheung DY, Lee HL, Lee DH, Kim GH, Choi SC, Cho YK, Chung WC, Kim JW, Yu E, Kwon H, Kim J, Kim J, Jung HY. Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis. Am J Gastroenterol. 2025 Feb 1;120(2):353-361. doi: 10.14309/ajg.0000000000002929. Epub 2024 Jul 3.

    PubMed 38976448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JP-1366 20mg and Esomeprazole 40mg in people with Erosive Esophagitis, run by Onconic Therapeutics Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%) (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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