Non-erosive Gastroesophageal Reflux DiseasePhase 3NCT07160790
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux Disease
A Phase 3 study of Non-erosive Gastroesophageal Reflux Disease, run by Onconic Therapeutics Inc..
Trial summary
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-erosive Gastroesophageal Reflux Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2025to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux(NERD) Disease: Double-blind, Randomized
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
- Being tested
- JP-1366 + placebo, Placebo + Placebo
- Keywords
- Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366 + placeboDrug
taking JP-1366 + placebo
Placebo + PlaceboDrug
taking placebo + placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1: JP-1366 A mg + Placebo | Experimental | Not described Receives: Drug: JP-1366 + placebo |
| Group 2: JP-1366 B mg + Placebo | Experimental | Not described Receives: Drug: JP-1366 + placebo |
| Placebo + Placebo | Placebo comparator | Not described Receives: Drug: Placebo + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of days with no heartburn
Measured: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160790
- Sponsor's protocol ID
- JP-1366-305
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of JP-1366 in Patients With Non-erosive Gastroesophageal Reflux(NERD) Disease: Double-blind, Randomized
- ClinicalTrials.gov ID
- NCT07160790
- Acronym / sponsor ID
- JP-1366-305
- Keywords
- Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of JP-1366 in Patients with NERD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: JP-1366 A mg + Placebo | Experimental | Drug: JP-1366 + placebo |
| Group 2: JP-1366 B mg + Placebo | Experimental | Drug: JP-1366 + placebo |
| Placebo + Placebo | Placebo comparator | Drug: Placebo + Placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JP-1366 + placebotaking JP-1366 + placebo | Drug | Group 1: JP-1366 A mg + Placebo, Group 2: JP-1366 B mg + Placebo |
| Placebo + Placebotaking placebo + placebo | Drug | Placebo + Placebo |
Primary outcome
The proportion of days with no heartburn
Time frame: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Non-erosive Gastroesophageal Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Not yet recruiting
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
Nocturnal Symptoms of GERD, Sleep Disorders in GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Non-erosive Gastroesophageal Reflux Disease, run by Onconic Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 proportion of days with no heartburn (time frame: The proportion of days with no heartburn for 24 hours (daytime/nighttime) over 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.