Stomach UlcerPhase 4NCT00233389
Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
A Phase 4 study testing Rebamipide in people with Stomach Ulcer, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study 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
- How many people
- 301 participants
- Where
- 1 siteJapan
- Study dates
- 30 Apr 2004to 9 Sep 2005
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years or older at time of consent
- H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
- Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: ->5 mm
- Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
Who cannot join
- Patients who have previously received H. pylori eradication therapy
- Patients with acute gastric ulcer
- Patients with linear ulcer
- Patients with complication of duodenal ulcer (excluding cicatrix)
- Patients who have undergone upper-GI tract or vagal nerve resection
- Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
Show all 14Show fewer
- Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
- Patients with a history of amoxicillin shock
- Patients with infectious mononucleosis
- Patients with severe renal disorders
- Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
- Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
- Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
- Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study
- Conditions
- Stomach Ulcer
- Being tested
- Rebamipide
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study start30 Apr 2004
- Primary completion1 Sep 2005
- Study completion9 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stomach UlcerStudies of the same condition, open and under way.
- More trials run by Otsuka 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
- Double blind
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katsuhisa Saito, Study director, Division of New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233389
- Sponsor's protocol ID
- C03700-003
- Other IDs
- JapicCTI-050035
- Status last verified
- May 2021
- First submitted
- 4 Oct 2005
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT00233389
- Acronym / sponsor ID
- C03700-003
- Conditions
- Stomach Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2004 (actual)
- Primary completion
- 1 Sep 2005 (actual)
- Study completion
- 9 Sep 2005 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Posted 4 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 years or older at time of consent
- H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
- Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: ->5 mm
- Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
Key exclusion criteria (14 listed)
- Patients who have previously received H. pylori eradication therapy
- Patients with acute gastric ulcer
- Patients with linear ulcer
- Patients with complication of duodenal ulcer (excluding cicatrix)
- Patients who have undergone upper-GI tract or vagal nerve resection
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 |
|---|---|---|
| Rebamipide | Drug | – |
Primary outcome
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
Time frame: Week 8
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katsuhisa Saito study director
Division of New Product Evaluation and Development
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 Rebamipide in people with Stomach Ulcer, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 4 inclusion and 14 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 4 Jun 2021. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8 (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 4 Jun 2021.