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CompletedNCT05656092Updated Feb 19, 2025

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

A Phase 3 interventional study of HIP0612 and HPP2202 in Gastric Ulcer, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Gastric Ulcer
03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 199 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
199 participants (actual)

Study arms

  • Experimental
    HIP0612

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

    Drug: HIP0612 · Drug: HPP2202

  • Active comparator
    RLD2204

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

    Drug: RLD2204 · Drug: HPP2201

Interventions

  • DrugHIP0612

    Test drug

  • DrugHPP2202

    Placebo drug

  • DrugRLD2204

    Reference drug

  • DrugHPP2201

    Placebo drug

06

What researchers measure

Primary outcomes

  1. Healing rate of gastric ulcer

    Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study

    Time frame: week 8

Secondary outcomes

  1. Healing rate of gastric ulcer

    Time frame: week 4

  2. Healing rate of gastric ulcer according to H.pylori infection status

    Time frame: week 4, 8

  3. Post-treatment resolution rate of GI symptoms

    Time frame: week 4, 8

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05656092
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Dec 19, 2022
Start date
Mar 6, 2023
Primary completion
Dec 19, 2024
Completion
Dec 19, 2024
Last update
Feb 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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