Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease
NCT ID: NCT07160790
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
321 participants
INTERVENTIONAL
2025-09-02
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: JP-1366 A mg + Placebo
JP-1366 + placebo
taking JP-1366 + placebo
Group 2: JP-1366 B mg + Placebo
JP-1366 + placebo
taking JP-1366 + placebo
Placebo + Placebo
Placebo + Placebo
taking placebo + placebo
Interventions
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JP-1366 + placebo
taking JP-1366 + placebo
Placebo + Placebo
taking placebo + placebo
Eligibility Criteria
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Inclusion Criteria
* Subjects in whom no mucosal breaks were observed on upper GI endoscopy at Visit 1 by LA Classification
* Subjects who fully understand this clinical trial and voluntarily signed the informed consent form
Exclusion Criteria
* Subjects who have a history of recent substance abuse, malignancy, systemic autoimmune or immune deficiency diseases, refractory response to PPI/P-CAB, hypersensitivity to study drugs, genetic metabolic disorders, or significant psychiatric conditions.
* Subjects who showed clinically significant abnormalities in laboratory tests
* Positive result in the H. pylori test
* Pregnant or breast-feeding women
* Subjects who require hospitalization are scheduled to undergo surgery during the study period, or have undergone major surgery requiring general anesthesia
* Other people deemed unsuitable for participation in this study according to the medical opinion of the investigator
19 Years
75 Years
ALL
No
Sponsors
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Onconic Therapeutics Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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JP-1366-305
Identifier Type: -
Identifier Source: org_study_id
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