A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05656092

Collaborator

(none)

226

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

Condition or Disease	Intervention/Treatment	Phase
Gastric Ulcer	Drug: HIP0612 Drug: HPP2202 Drug: RLD2204 Drug: HPP2201	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients With Gastric Ulcer

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIP0612 Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.	Drug: HIP0612 Test drug Drug: HPP2202 Placebo drug
Active Comparator: RLD2204 Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.	Drug: RLD2204 Reference drug Drug: HPP2201 Placebo drug

Arm

Intervention/Treatment

Experimental: HIP0612

Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.

Drug: HIP0612

Test drug

Drug: HPP2202

Placebo drug

Active Comparator: RLD2204

Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.

Drug: RLD2204

Reference drug

Drug: HPP2201

Placebo drug

Outcome Measures

Primary Outcome Measures

Healing rate of gastric ulcer [week 8]
Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study

Secondary Outcome Measures

Healing rate of gastric ulcer [week 4]
Healing rate of gastric ulcer according to H.pylori infection status [week 4, 8]
Post-treatment resolution rate of GI symptoms [week 4, 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

19 years to 75 years
Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

Patients who cannot perform endoscopy
Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
Severe hepatic disease
Severe renal disease, CKD
Bleeding disorder
History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
Patients who have taken drugs containing following list within 1 weeks prior to upper

GI endoscopy, or requirement of persistent use of drugs during the study period:

antithrombotic agents, NSAIDs, aspirin

Requirement of use of excluded medications during the study
History of allergic reaction to the medications used in this study
Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
Use of other investigational drugs within 30 days prior to the study
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT05656092

Other Study ID Numbers:

HM-AESOP-301

First Posted:

Dec 19, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Ulcer

Ulcer

Study Results

No Results Posted as of Dec 22, 2022