Gastric UlcerPhase 3NCT05656092
A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer
A Phase 3 study testing HIP0612, HPP2202 and RLD2204 in people with Gastric Ulcer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- HIP0612, HPP2202 and RLD2204
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2023to 19 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.
- Conditions
- Gastric Ulcer
- Being tested
- HIP0612, HPP2202, RLD2204, HPP2201
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP0612Drug
Test drug
HPP2202Drug
Placebo drug
RLD2204Drug
Reference drug
HPP2201Drug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| HIP0612 | Experimental | Taking HIP0612+HPP2202 once daily for 4 or 8 weeks. Receives: Drug: HIP0612; Drug: HPP2202 |
| RLD2204 | Active comparator | Taking RLD2204+HPP2201 once daily for 4 or 8 weeks. Receives: Drug: RLD2204; Drug: HPP2201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate of gastric ulcer
Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study
Measured: week 8
Secondary outcomes (3)
Healing rate of gastric ulcer
Measured: week 4
Healing rate of gastric ulcer according to H.pylori infection status
Measured: week 4, 8
Post-treatment resolution rate of GI symptoms
Measured: week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 Mar 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656092
- Sponsor's protocol ID
- HM-AESOP-301
- Status last verified
- Feb 2025
- First submitted
- 9 Dec 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05656092
- Acronym / sponsor ID
- HM-AESOP-301
- Conditions
- Gastric Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIP0612 | Experimental | Drug: HIP0612, Drug: HPP2202Taking HIP0612+HPP2202 once daily for 4 or 8 weeks. |
| RLD2204 | Active comparator | Drug: RLD2204, Drug: HPP2201Taking RLD2204+HPP2201 once daily for 4 or 8 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP0612Test drug | Drug | HIP0612 |
| HPP2202Placebo drug | Drug | HIP0612 |
| RLD2204Reference drug | Drug | RLD2204 |
| HPP2201Placebo drug | Drug | RLD2204 |
Primary outcome
Healing rate of gastric ulcer
Time frame: week 8
Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study
3 secondary outcomes
Healing rate of gastric ulcer
Time frame: week 4
Healing rate of gastric ulcer according to H.pylori infection status
Time frame: week 4, 8
Post-treatment resolution rate of GI symptoms
Time frame: week 4, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HIP0612, HPP2202 and RLD2204 in people with Gastric Ulcer, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate of gastric ulcer (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.