JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis

NCT05443984 | Completed Phase 3

• 1 other identifier: JP-1366-301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of JP-1366 20 mg compared to esomeprazole 40 mg in patients with erosive esophagitis

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)

  The proportion of subjects with remission on endoscopy at 8-week

  Week 8

Secondary Outcomes (6)

• Healing rate of mucosal break at the 4-week after the investigational product administration

  Week 4

• Healing rate of mucosal break evaluated by an independent evaluator at the 4-week after the investigational product administration

  Week 4

• The cumulative Healing rate of mucosal break evaluated by an independent evaluator at the 8-week after the investigational product administration

  Week 8

• Symptom assessment according to the RDQ questionnaire

  Week 4 and 8

• Gastro-esophageal symptoms assessment through subject diary at 4, 8 weeks

  within 24hours after IP administration, during 7days after IP administration, Week 4 and 8

Other Outcomes (1)

• Exploratory variables

  Week 4 and 8

Study Arms (2)

Experimental Group

EXPERIMENTAL

JP-1366 20mg + Esomeprazole 40mg(placebo)

Drug: JP-1366 20mg

Active Comparative Group

ACTIVE COMPARATOR

JP-1366 20mg(placebo) + Esomeprazole 40mg

Drug: Esomeprazole 40mg

Interventions

JP-1366 20mg DRUG

1 capsule of JP-1366 20 mg, 1 tablet of esomeprazole placebo (irrespective of meals)

Experimental Group

Esomeprazole 40mg DRUG

1 capsule of JP-1366 placebo, 1 tablet of esomeprazole 40 mg placebo (irrespective of meals)

Active Comparative Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 19 years of age at the time of obtaining consent
• Subjects who had experienced heartburn and regurgitation within 7 days prior to the screening visit, those whose severity and frequency of symptoms fall under the following (1) or (2)
• ⑴ Subjects who have experienced mild or more severe heartburn or regurgitation at least twice a week
• ⑵ Subjects who have experienced moderate or more severe heartburn or regurgitation at least once a week
• Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization
• Subjects who fully understand this study and voluntarily signed on the informed consent form

You may not qualify if:

• Subjects who can't undergo endoscopy
• Medical History
• º Subjects who have warning symptoms of the malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (except negative result for malignancy by endoscopy)
• º Subjects with eosinophilic esophagitis (except negative result by esophageal biopsy)
• º Subjects who have esophageal stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumor confirmed by EGD
• º Zollinger-Ellison syndrome patients
• º Subjects diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected with IBS in the last 3 months and with a current history of the disease including pancreatitis
• º Subjects who have a history of gastric acid suppression surgery, gastrointestinal or esophageal surgery (except appendectomy, cholecystectomy, polypectomy)
• º Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, urinary, neuro-psychiatric, hemato-oncologic disorder
• º Subjects who have a history of malignant tumor in 5 years at the time of screening. However, excluding subjects with malignant gastrointestinal cancer regardless of the period.
• Laboratory Test
• Screening laboratory test showing any of the following abnormal laboratory results:
• º ALT or AST \> 2.0 x ULN
• º ALP or GGT \> 2.0 x ULN
• º Total bilirubin \> 2.0 x ULN

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Asan Medical Center and 26 hospitals

Seoul, South Korea

Location

Related Publications (1)

• Oh JH, Kim HS, Cheung DY, Lee HL, Lee DH, Kim GH, Choi SC, Cho YK, Chung WC, Kim JW, Yu E, Kwon H, Kim J, Kim J, Jung HY. Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis. Am J Gastroenterol. 2025 Feb 1;120(2):353-361. doi: 10.14309/ajg.0000000000002929. Epub 2024 Jul 3.

  PMID: 38976448 DERIVED

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: January 17, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: August 27, 2024

Record last verified: 2022-07

Locations

KR (1)