Stomach UlcerNCT01167101
Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?
A study testing Rebamipide and pantoprazole in people with Stomach Ulcer, run by Kangdong Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). 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 pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Dec 2010
- Phase
- Interventional
- 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 underwent ESD for gastric adenoma or cancer
Who cannot join
- subjects with previous gastric surgery
- subjects taking aspirin, anticoagulant, or antiplatelet agent
- subjects having malignancy except gastric cancer
- pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.
- Conditions
- Stomach Ulcer
- Being tested
- Rebamipide, pantoprazole
- Keywords
- Rebamipide, gastric ulcer, healing rate, iatrogenic gastric ulcer after endoscopic submucosal dissection
- 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
Rebamipide 100mg Tid for 28days
pantoprazoleDrug
pantoprazole 40mg qd for 28days
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole | Other | controls Pantoprazole 40mg qd for 28days Receives: Drug: pantoprazole |
| Pantoprazole + Rebamipde | Active comparator | Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days Receives: Drug: Rebamipide; Drug: pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.
Measured: at 2month after endoscopic submucosal dissection (ESD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangdong Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin, Woon Geon, Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167101
- Sponsor's protocol ID
- 08-62
- Status last verified
- Sep 2015
- First submitted
- 20 Jul 2010
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shin WG, Kim SJ, Choi MH, Kim KO, Jang HJ, Park CH, Baek IH, Kim KH, Baik GH, Kae SH, Kim JH, Kim HY. Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.
PubMed 22281110
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
- ClinicalTrials.gov ID
- NCT01167101
- Acronym / sponsor ID
- 08-62
- Conditions
- Stomach Ulcer
- Keywords
- Rebamipide, gastric ulcer, healing rate, iatrogenic gastric ulcer after endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Kangdong Sacred Heart HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jul 2010 (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.
Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole | Other | Drug: pantoprazolecontrols Pantoprazole 40mg qd for 28days |
| Pantoprazole + Rebamipde | Active comparator | Drug: Rebamipide, Drug: pantoprazolePantoprazole 40mg qd + Rebamipide 100mg Tid for 28days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients underwent ESD for gastric adenoma or cancer
Key exclusion criteria (4 listed)
- subjects with previous gastric surgery
- subjects taking aspirin, anticoagulant, or antiplatelet agent
- subjects having malignancy except gastric cancer
- pregnant or breast-feeding 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 |
|---|---|---|
| RebamipideRebamipide 100mg Tid for 28days | Drug | Pantoprazole + Rebamipde |
| pantoprazolepantoprazole 40mg qd for 28days | Drug | Pantoprazole, Pantoprazole + Rebamipde |
Primary outcome
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
Time frame: at 2month after endoscopic submucosal dissection (ESD)
Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.
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 4 Sep 2015.
- Derived from this study: PubMed 22281110Shin WG, Kim SJ, Choi MH, Kim KO, Jang HJ, Park CH, Baek IH, Kim KH, Baik GH, Kae SH, Kim JH, Kim HY. Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study. Gastrointest Endosc. 2012 Apr;75(4):739-47. doi: 10.1016/j.gie.2011.11.004. Epub 2012 Jan 26.
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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 study testing Rebamipide and pantoprazole in people with Stomach Ulcer, run by Kangdong Sacred Heart Hospital 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 1 inclusion and 4 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 Sep 2015. 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.
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 efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer (time frame: at 2month after endoscopic submucosal dissection (ESD)). 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 NCT01167101, 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 4 Sep 2015.