Not yet recruiting NCT07160790
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JP-1366 + placebo, Placebo + Placebo.
- Who it may be relevant to
- Registry conditions: Non-erosive Gastroesophageal Reflux Disease. Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux(NERD) Disease: Double-blind, Randomized
Overview
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
Interventions
- Drug JP-1366 + placebo
taking JP-1366 + placebo - Drug Placebo + Placebo
taking placebo + placebo
Primary outcome measures
- The proportion of days with no heartburn [Time frame: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07160790 · JP-1366-305