Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366... | NCT07160790

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

NCT07160790

Sponsor

Onconic Therapeutics Inc.

Status

Not yet recruiting

Last Update Posted

Sep 8, 2025Actual

Enrollment

321Estimated

Phase

Phase 3

Conditions

Non-erosive Gastroesophageal Reflux Disease

Interventions

JP-1366 + placebo
Placebo + Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2025Estimated

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Aug 29, 2025

First Submission Date that Met QC Criteria

Aug 29, 2025

First Posted Date

Sep 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

321Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JP-1366 + placebo	Drug	taking JP-1366 + placebo	Group 1: JP-1366 A mg + Placebo Group 2: JP-1366 B mg + Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000096663	Non-Erosive Reflux Disease

Ancestor Terms

ID	Term
D005764	Gastroesophageal Reflux
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided