Stomach UlcerPhase 4NCT00272467
Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
A Phase 4 study testing Rebamipide and Omeprazole in people with Stomach Ulcer, run by Korea Otsuka International Asia Arab at 7 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Ulcer
- What is being tested?
- Rebamipide and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2005to Apr 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 or older at the time of writing the informed consent
- H. pylori-positive patient.
- Patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; Non-scarring ulcer (stage A1, A2, H1, H2 according to the Sakita-Miwa classification), Single ulcer, Ulcer size of 5 to 20mm in diameter
Who cannot join
- Patients who previously underwent H. pylori eradication therapy
- Malignant gastric ulcer
- Linear ulcer
- Patients with history of upper GI tract resection or vagotomy
- Patients with continuous NSAIDs use within 4 weeks prior to study initiation
- Patients with ulcer complications including perforation or pyloric stenosis
Show all 13Show fewer
- Gastric ulcer prone to bleeding (e.g. exposed blood vessels at ulcer base)
- Patients with infectious mononucleosis
- Patients with known hypersensitivity to penicillin, clarithromycin, omeprazole, amoxicillin or rebamipide
- Patients on medications such as terfenadine or pimozide which are contraindicated with clarithromycin usage
- Pregnant or possibly pregnant women, lactating women, or those with a plan to conceive during this study
- Blood test results of Hb ≤ 8.0 g/dl, platelet ≤50,000 /㎕, total WBC ≤ 4000/㎕ or ≥ 10,000/㎕, and with serum test results showing the levels of AST, ALT, ALP, LDH, BUN, and creatinine exceeding twice the normal range of respective institution.
- Other patients deemed not eligible for this study by investigators
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China5 sites
The 1st Affiliated hospital - Zhongshan Univ.
Guangzhou, Guangdong, 510080
Nanfang Hospital - Nanfang Medical Univ.
Guangzhou, Guangdong, 510515
The 1st Affiliated Hospital - Medical School of Zhejiang Univ.
Hangzhou, Zhejiang, 310003
Ren-Ji Hospital - Shanghai Second Medical Univ.
Shanghai, 200001
Xijing Hospital - The 4th Military Medical Univ
Xi’an, Shanxi, 710032
South Korea2 sites
Korea University Ansan Hospital
Ansan, 425-707
Severance Hospital, Seoul National University
Seoul, 120-752
About this study
Official title: A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.
Read the detailed description
This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.
- Conditions
- Stomach Ulcer
- Being tested
- Rebamipide, Omeprazole
- Keywords
- Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Also called Mucosta
- Brand name: Mucosta® Tab.
- Generic name: Rebamipide.
- Chemical name: (±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid.
- Formulation: Tablet (White, film-coated tablet).
- Strength: One tablet contains rebamipide 100mg.
- Storage condition: 15℃~25℃.
- Manufacturer: Korea Otsuka Pharmaceuticals
OmeprazoleDrug
Also called Losec
- Brand name: Losec® Cap.
- Generic name: Omeprazole.
- Chemical name:
5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃~25℃. 7) Manufacturer: AstraZenaca Korea.
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide | Experimental | 1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed).
2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks Receives: Drug: Rebamipide |
| Omeprazole | Active comparator | 1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast)
2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric ulcer healing rate
Rebamipide showed 81.5~87.8% of gastric ulcer healing rate which was not inferior to 82.5~87.8% healing rate of Omeprazole.
Measured: at 12 weeks after the initial administration of the study medication
Secondary outcomes (3)
Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
Measured: at 12 weeks after the initial administration of the study medication
Serum gastrin level
Measured: at 8 and 12 weeks after the initial administration of study medication
Economical efficiency
Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.
Measured: drug cost/effect ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startJul 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka International Asia Arab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd., Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jin-Ho Kim, M.D., Principal investigator, Asan Medical Center, Ulsan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272467
- Sponsor's protocol ID
- OIAAMCTIVK205
- Status last verified
- Apr 2015
- First submitted
- 4 Jan 2006
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
- ClinicalTrials.gov ID
- NCT00272467
- Acronym / sponsor ID
- OIAAMCTIVK205
- Conditions
- Stomach Ulcer
- Keywords
- Helicobacter pylori, Stomach ulcer, Rebamipide, Omeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Korea Otsuka International Asia ArabIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Otsuka Pharmaceutical Co., Ltd., Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jul 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Jan 2006 (estimated)
- 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 evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.
Detailed description
This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebamipide | Experimental | Drug: Rebamipide1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed). 2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks |
| Omeprazole | Active comparator | Drug: Omeprazole1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast) 2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 or older at the time of writing the informed consent
- H. pylori-positive patient.
- Patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; Non-scarring ulcer (stage A1, A2, H1, H2 according to the Sakita-Miwa classification), Single ulcer, Ulcer size of 5 to 20mm in diameter
Key exclusion criteria (13 listed)
- Patients who previously underwent H. pylori eradication therapy
- Malignant gastric ulcer
- Linear ulcer
- Patients with history of upper GI tract resection or vagotomy
- Patients with continuous NSAIDs use within 4 weeks prior to study initiation
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 |
|---|---|---|
| RebamipideAlso: Mucosta1. Brand name: Mucosta® Tab. 2. Generic name: Rebamipide. 3. Chemical name: (±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]propionic acid. 4. Formulation: Tablet (White, film-coated tablet). 5. Strength: One tablet contains rebamipide 100mg. 6. Storage condition: 15℃~25℃. 7. Manufacturer: Korea Otsuka Pharmaceuticals | Drug | Rebamipide |
| OmeprazoleAlso: Losec1. Brand name: Losec® Cap. 2. Generic name: Omeprazole. 3. Chemical name: 5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃~25℃. 7) Manufacturer: AstraZenaca Korea. | Drug | Omeprazole |
Primary outcome
Gastric ulcer healing rate
Time frame: at 12 weeks after the initial administration of the study medication
Rebamipide showed 81.5~87.8% of gastric ulcer healing rate which was not inferior to 82.5~87.8% healing rate of Omeprazole.
3 secondary outcomes
Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)
Time frame: at 12 weeks after the initial administration of the study medication
Serum gastrin level
Time frame: at 8 and 12 weeks after the initial administration of study medication
Economical efficiency
Time frame: drug cost/effect ratio
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 29 Apr 2015.
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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.
Jin-Ho Kim, M.D. principal investigator
Asan Medical Center, Ulsan University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebamipide and Omeprazole in people with Stomach Ulcer, run by Korea Otsuka International Asia Arab at 7 sites in 2 countries.
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 13 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, 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?
Gastric ulcer healing rate (time frame: at 12 weeks after the initial administration of the study medication). 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 29 Apr 2015.