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Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease

ConditionNon-erosive Gastroesophageal Reflux Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorOnconic Therapeutics Inc.

About this trial

This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who have experienced both heartburn and acid regurgitation

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

Disqualifiers

Subjects who have significant gastrointestinal diseases or procedures affecting the esophagus, stomach, or duodenum

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • JP-1366 + placebo

    Drug

    taking JP-1366 + placebo

  • Placebo + Placebo

    Drug

    taking placebo + placebo

Treatment groups

321 Participants
are divided into 3 treatment groups
Group A: Group 1: JP-1366 A mg + PlaceboExperimental treatment 1 intervention
Group B: Group 2: JP-1366 B mg + PlaceboExperimental treatment 1 intervention
Group C: Placebo + PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of days with no heartburn

Time frame
The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onconic Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: