GastritisPhase 4NCT05072938
Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
A Phase 4 study testing Mucotra SR Tablet 150mg and Axid Capsule 150mg in people with Gastritis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Gastritis
- What is being tested?
- Mucotra SR Tablet 150mg and Axid Capsule 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2021to 15 Dec 2022
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 19 years or older and under 75 years
- Subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer)
- Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.
Who cannot join
- Subject who is unable to examine the upper gastrointestinal endoscope
- A person with the following past history
- Surgery to suppress gastric acid secretion or gastrointestinal and esophagus surgery
- Malignant tumor of the digestive system
- overreacted to the components of medicine for clinical trials and H2 receptor blockers
- Drug or alcohol abuse
Show all 21Show fewer
- A person accompanied by the following diseases
- Digestive ulcers (excluding half a scar)
- Reflux esophagitis
- Inflammatory bowel disease (cron disease, ulcerative colitis)
- Thrombotic diseases (such as cerebral thrombosis, myocardial infarction, thrombotic venous inflammation, etc.)
- Zollinger-Ellison syndrome
- Subject with mental illness, cardiovascular system, respiratory system, endocrine system, central nervous system who the investigator determined that it is difficult to participate in this clinical trial
- A person who needs to administer a taboo drug during the clinical trial period.
- Pregnant women and nursing women
- Fertilized women and men who have a pregnancy plan or do not have the will to use the appropriate contraceptive method during the clinical trial period.
- Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- Severe liver disorder (AST or ALT > 3 times the normal upper limit of the organ)
- Serious nephropathy (creatinine clearance < 50 mL/min)
- Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
- Subject who the investigator determined it is inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea c St. Mary's Hospital
Seoul
About this study
Official title: A Multi-center, Open-label, Randomized, Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis
Read the detailed description
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis.
Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.
- Conditions
- Gastritis
- Being tested
- Mucotra SR Tablet 150mg, Axid Capsule 150mg
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucotra SR Tablet 150mgDrug
Also called Mucotra
Rebamipide/Nizatidine Combination Therapy
Axid Capsule 150mgDrug
Also called Axid
Nizatidine Monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Nizatidine Monotherapy | Active comparator | Nizatidine Monotherapy Receives: Drug: Axid Capsule 150mg |
| Rebamipide/Nizatidine Combination Therapy | Experimental | Rebamipide/Nizatidine Combination Therapy Receives: Drug: Mucotra SR Tablet 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline
Measured: 2 weeks
Secondary outcomes (6)
Erosion cure rate on upper gastrointestinal endoscopy
Erosion cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Measured: 2 weeks
Effective rate of bleeding on upper gastrointestinal endoscopy
Effective rate of bleeding on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Measured: 2 weeks
Effective rate of flares on upper gastrointestinal endoscopy
Effective rate of flares on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Measured: 2 weeks
Edema cure rate on upper gastrointestinal endoscopy
Edema cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Measured: 2 weeks
Validity rate of subjective symptom scores evaluated by subjects
Validity rate of subjective symptom scores evaluated by subjects at 2 weeks compared to baseline
Measured: 2 weeks
Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline
Change in total subjective symptom score and individual symptom score assessed by the subject
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start30 Sep 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Kyu Choi, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072938
- Sponsor's protocol ID
- MUC0S-P401
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
- ClinicalTrials.gov ID
- NCT05072938
- Acronym / sponsor ID
- MUC0S-P401
- Conditions
- Gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 11 Oct 2021 (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.
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis
Detailed description
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis.
Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nizatidine Monotherapy | Active comparator | Drug: Axid Capsule 150mgNizatidine Monotherapy |
| Rebamipide/Nizatidine Combination Therapy | Experimental | Drug: Mucotra SR Tablet 150mgRebamipide/Nizatidine Combination Therapy |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 19 years or older and under 75 years
- Subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer)
- Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.
Key exclusion criteria (21 listed)
- Subject who is unable to examine the upper gastrointestinal endoscope
- A person with the following past history
- A person accompanied by the following diseases
- A person who needs to administer a taboo drug during the clinical trial period.
- Pregnant women and nursing women
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 |
|---|---|---|
| Mucotra SR Tablet 150mgAlso: MucotraRebamipide/Nizatidine Combination Therapy | Drug | Rebamipide/Nizatidine Combination Therapy |
| Axid Capsule 150mgAlso: AxidNizatidine Monotherapy | Drug | Nizatidine Monotherapy |
Primary outcome
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
Time frame: 2 weeks
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline
6 secondary outcomes
Erosion cure rate on upper gastrointestinal endoscopy
Time frame: 2 weeks
Effective rate of bleeding on upper gastrointestinal endoscopy
Time frame: 2 weeks
Effective rate of flares on upper gastrointestinal endoscopy
Time frame: 2 weeks
Edema cure rate on upper gastrointestinal endoscopy
Time frame: 2 weeks
Validity rate of subjective symptom scores evaluated by subjects
Time frame: 2 weeks
Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline
Time frame: 2 weeks
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 1 Jul 2024.
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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.
Myung Kyu Choi principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mucotra SR Tablet 150mg and Axid Capsule 150mg in people with Gastritis, run by Daewoong Pharmaceutical Co. LTD. 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 21 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 1 Jul 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy (time frame: 2 weeks). 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 1 Jul 2024.