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

Gastric Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05656092
• Other study ID #: HM-AESOP-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Minsook Jung
• Phone: +82)-2-410-0442
• Email: jungms[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Ulcer
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• HIP0612
Test drug
• HPP2202
Placebo drug
• RLD2204
Reference drug
• HPP2201
Placebo drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate of gastric ulcer	Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study	week 8
Secondary	Healing rate of gastric ulcer		week 4
Secondary	Healing rate of gastric ulcer according to H.pylori infection status		week 4, 8
Secondary	Post-treatment resolution rate of GI symptoms		week 4, 8