NCT04282954

Brief Summary

Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2020

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

February 21, 2020

Last Update Submit

July 11, 2022

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

  • Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)

    \* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy

    8 weeks

Study Arms (4)

Group 1

EXPERIMENTAL

JP-1366 A mg

Drug: JP-1366Drug: JP-1366 placeboDrug: Esomeprazole placebo

Group 2

EXPERIMENTAL

JP-1366 B mg

Drug: JP-1366Drug: JP-1366 placeboDrug: Esomeprazole placebo

Group 3

EXPERIMENTAL

JP-1366 C mg

Drug: JP-1366Drug: JP-1366 placeboDrug: Esomeprazole placebo

Goup 4

ACTIVE COMPARATOR

Esomeprazole 40 mg

Drug: JP-1366 placeboDrug: Esomeprazole 40mg

Interventions

JP-1366DRUG

JP-1366, QD

Group 1Group 2Group 3
JP-1366 placeboDRUG

JP-1366 placebo, QD

Goup 4Group 1Group 2Group 3
Esomeprazole 40mgDRUG

Esomeprazole 40mg, QD

Goup 4
Esomeprazole placeboDRUG

Esomeprazole placebo, QD

Group 1Group 2Group 3

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 19 and 75 years old based on the date of written agreement
  • Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
  • Those who experienced symptoms of heartburn or acid reflux within the last 7 days

You may not qualify if:

  • Those who have undergone gastric acid suppression or gastric, esophageal surgery
  • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
  • Clinically significant abnormal laboratory values during screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital and 19 hospitals

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

November 15, 2019

Primary Completion

October 20, 2020

Study Completion

December 11, 2020

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)