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GastritisPhase 3NCT05024721

Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

A Phase 3 study testing HIP2101, RLD2101 and HPP2101 in people with Gastritis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Gastritis
What is being tested?
HIP2101, RLD2101 and HPP2101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
1 siteSouth Korea
Study dates
9 Aug 2021to 7 Mar 2022
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≤ age ≤ 75
  • Have been diagnosed as acute or chronic gastritis with at least 1 erosion by endoscopy within 7 days before enrollment.
  • Patients understood the consents and purpose of this trial and signed consent form

Who cannot join

  • Patients who cannot perform endoscopy
  • Active gastric or duodenal ulcer
  • Reflux esophagitis, barrett's esophagus, gastric or esophageal varix
  • Zollinger-Ellison syndrome, pyloric obstruction, and esophageal stricture, Inflammatory Bowel Diease, acute pancreatitis
  • History of gastrointestinal surgery
  • History of malignancy tumor, especially in the upper gastrointestinal tract
Show all 17Show fewer
  • Severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
  • Severe renal disorder(at screening day, MDRD eGFP ≤ 30 mL/min/1.73m2) or chronic renal disease
  • Bleeding disorder
  • Patients who have taken drugs containing following list within 2 weeks before endoscopy : H2-receptor antagonists, Proton pump inhibitors, P-CABs, gastrin inhibitors, antacids, gastric mucosal protectants, anticholinergics
  • Patients who have taken anticoagulants within a week before endoscopy
  • Patients who have taken drugs containing following list after endoscopy : GI tract regulators, salicylates, steroids, , NSAIDs, bisphosphonates, selective serotonin reuptake inhibitors, iron supplements, oriental herbal medicines
  • History of allergic reaction to the medications used in this study
  • 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.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis

The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in patients with acute or chronic gastritis.

Conditions
Gastritis
Being tested
HIP2101, RLD2101, HPP2101, HPP2102
Medical subject headings
Gastritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIP2101Drug

    Test drug

  • RLD2101Drug

    Reference drug

  • HPP2101Drug

    Placebo drug

  • HPP2102Drug

    Placebo drug

Study groups in NCT05024721
Study groupRoleWhat they receive
HIP2101ExperimentalTaking HIP2101+HPP2102 once daily for 2 weeks.
Receives: Drug: HIP2101; Drug: HPP2102
RLD2101Active comparatorTaking RLD21012101+HPP2101 once daily for 2 weeks.
Receives: Drug: RLD2101; Drug: HPP2101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement rate of erosion

    percentage of subjects whose erosion score is improved by more than 50%

    Measured: week 2

Secondary outcomes (5)

  1. Cure rate of erosion

    percentage of subjects whose erosion is completely cured

    Measured: week 2

  2. Cure rate of edema

    percentage of subjects whose edema is completely cured

    Measured: week 2

  3. Improvement rate of erythema

    percentage of subjects whose erythema score is improved by more than 50%

    Measured: week 2

  4. Improvement rate of hemorrage

    percentage of subjects whose hemorrage score is improved by more than 50%

    Measured: week 2

  5. Improvement rate of GI symptoms

    percentage of subjects whose GI symptoms score is improved by more than 50%

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start9 Aug 2021
  3. Primary completion7 Mar 2022
  4. Study completion7 Mar 2022

Resources

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
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024721
Sponsor's protocol ID
HM-ESOL-301
Status last verified
Jul 2022
First submitted
23 Aug 2021
Last updated
14 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lim H, Lee JY, Kwon YH, Moon HS, Park JK, Kim KB, Kim SW, Youn YH, Kim SG, Kim GH, Kim JW, Jang JY, Kwon KS, Kwon JG, Kim HS, Hong SJ, Lee KJ, Choi SC, Moon JS, Kim N, Park JJ, Lim Y, Hong SH, Jung HY. Evaluation of the Efficacy and Safety of a Dual Delayed-Release Formulation of 10-mg Esomeprazole in Patients with Gastric Erosions: A Multicenter, Randomized, Double-Blind, Active-Control, Phase III Study. Gut Liver. 2025 Jul 15;19(4):519-527. doi: 10.5009/gnl240390. Epub 2025 Feb 14.

    PubMed 39949051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HIP2101, RLD2101 and HPP2101 in people with Gastritis, 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 14 Jul 2022. 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?

Improvement rate of erosion (time frame: week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05024721, which also lists 1 linked publication.

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 14 Jul 2022.

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