Clinical trial NCT05656092: A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-12-19
Enrollment: 199
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Healing rate of gastric ulcer
timeFrame: week 8
Secondary outcomes:
measure: Healing rate of gastric ulcer
timeFrame: week 4
measure: Healing rate of gastric ulcer according to H.pylori infection status
timeFrame: week 4, 8
measure: Post-treatment resolution rate of GI symptoms
timeFrame: week 4, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: