Peptic Ulcer HemorrhagePhase 4NCT00838682
Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
A Phase 4 study testing omeprazole sodium IV and Rabeprazole in people with Peptic Ulcer Hemorrhage, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- omeprazole sodium IV and Rabeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2006to Mar 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
- patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy
Who cannot join
- Patients who refuse endoscopic procedure
- Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
- Pregnancy
- Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
- History of previous gastrectomy or vagotomy
- Known hypersensitivity to proton pump inhibitors
- Elderly patients
- Epilepsy
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Bucheon St. Mary's Hospital
Bucheon-si, Kyungkido
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Kyungkido
About this study
This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.
Read the detailed description
0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding. Endoscopic hemostasis procedure in the management of bleeding due to peptic ulcers was safe as well as effective and lowered recurrent bleeding, surgery and mortality. Endoscopic treatment is widely used as an effective and safe method but it has disadvantages including the need for the endoscopy specialist and the likelihood of developing the complications such as perforation or recurrent bleeding although they rarely occur. Thus, less invasive medical treatments with fewer side effects have been continuously studied and among them, gastric acid inhibitors have been studied the most.Acid and pepsin inhibit platelet aggregation, activation of blood coagulation system, and fibrinogen polymerization. Blood clots already formed are digested by pepsin and the activity of pepsin is closely related to intragastric pH level. Therefore, it is known that an elevated intragastric pH facilitates hemostasis process, induces hemostasis by stabilizing hematoma and prevents recurrent bleeding. To suffice these conditions, it is reported that a potent gastric acid inhibitor is needed to maintain intragastric pH of 6 or higher.
For the treatment of bleeding peptic ulcers, the intravenous administration of a high-dose proton pump inhibitor after the initial endoscopic treatment has shown a decline in the frequency of recurrent bleeding as well as surgery. Recent studies reported that the use of oral proton pump inhibitor was effective under certain circumstances in the treatment of bleeding peptic ulcers. However, to date, no study has been conducted to compare the effect of a high-dose intravenous proton pump inhibitor with that of oral Rabeprazole after endoscopic treatment of bleeding peptic ulcers. Therefore, in this study, after administering a high-dose intravenous proton pump inhibitor or high-dose oral Rabeprazole in preventing recurrent bleeding following endoscopic treatment of bleeding peptic ulcers, we are going to compare the rate of recurrent bleeding between the two groups as well as to compare and evaluate the surgery rate, mortality rate and the number of days of hospital stay.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- omeprazole sodium IV, Rabeprazole
- Keywords
- peptic ulcer bleeding, rabeprazole, proton pump inhibitor
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazole sodium IVDrug
Also called Losec IV
Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
RabeprazoleDrug
Also called Pariet
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| rabeprazole sodium | Experimental | Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. Receives: Drug: Rabeprazole |
| Omeprazole | Active comparator | Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. Receives: Drug: omeprazole sodium IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding Within 3 Days
Measured: day 3
Secondary outcomes (3)
Rebleeding After 3 Days
Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.
Measured: 6wk
Surgery
This sencodary endpoint "surgery" is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy.
Measured: 6wk
Death
Measured: 6wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startApr 2006
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: Terminated before the complete enrollment due to slow enrollment
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 Peptic Ulcer HemorrhageStudies 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
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Investigators
- Hiun-Suk Chae, Professor, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838682
- Sponsor's protocol ID
- RAB-KOR-18
- Status last verified
- Aug 2010
- First submitted
- 5 Feb 2009
- Last updated
- 24 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
- ClinicalTrials.gov ID
- NCT00838682
- Acronym / sponsor ID
- RAB-KOR-18
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- peptic ulcer bleeding, rabeprazole, proton pump inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated before the complete enrollment due to slow enrollment
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Apr 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Posted 24 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.
Detailed description
0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding. Endoscopic hemostasis procedure in the management of bleeding due to peptic ulcers was safe as well as effective and lowered recurrent bleeding, surgery and mortality. Endoscopic treatment is widely used as an effective and safe method but it has disadvantages including the need for the endoscopy specialist and the likelihood of developing the complications such as perforation or recurrent bleeding although they rarely occur. Thus, less invasive medical treatments with fewer side effects have been continuously studied and among them, gastric acid inhibitors have been studied the most.Acid and pepsin inhibit platelet aggregation, activation of blood coagulation system, and fibrinogen polymerization. Blood clots already formed are digested by pepsin and the activity of pepsin is closely related to intragastric pH level. Therefore, it is known that an elevated intragastric pH facilitates hemostasis process, induces hemostasis by stabilizing hematoma and prevents recurrent bleeding. To suffice these conditions, it is reported that a potent gastric acid inhibitor is needed to maintain intragastric pH of 6 or higher.
For the treatment of bleeding peptic ulcers, the intravenous administration of a high-dose proton pump inhibitor after the initial endoscopic treatment has shown a decline in the frequency of recurrent bleeding as well as surgery. Recent studies reported that the use of oral proton pump inhibitor was effective under certain circumstances in the treatment of bleeding peptic ulcers. However, to date, no study has been conducted to compare the effect of a high-dose intravenous proton pump inhibitor with that of oral Rabeprazole after endoscopic treatment of bleeding peptic ulcers. Therefore, in this study, after administering a high-dose intravenous proton pump inhibitor or high-dose oral Rabeprazole in preventing recurrent bleeding following endoscopic treatment of bleeding peptic ulcers, we are going to compare the rate of recurrent bleeding between the two groups as well as to compare and evaluate the surgery rate, mortality rate and the number of days of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rabeprazole sodium | Experimental | Drug: RabeprazoleOral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. |
| Omeprazole | Active comparator | Drug: omeprazole sodium IVIntravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
- patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy
Key exclusion criteria (8 listed)
- Patients who refuse endoscopic procedure
- Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
- Pregnancy
- Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
- History of previous gastrectomy or vagotomy
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 |
|---|---|---|
| omeprazole sodium IVAlso: Losec IVIntravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. | Drug | Omeprazole |
| RabeprazoleAlso: ParietOral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy. | Drug | rabeprazole sodium |
Primary outcome
Rebleeding Within 3 Days
Time frame: day 3
3 secondary outcomes
Rebleeding After 3 Days
Time frame: 6wk
Surgery
Time frame: 6wk
Death
Time frame: 6wk
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
- 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.
Hiun-Suk Chae, Professor principal investigator
The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omeprazole sodium IV and Rabeprazole in people with Peptic Ulcer Hemorrhage, run by The Catholic University of Korea at 2 sites 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Sep 2010). 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?
Rebleeding Within 3 Days (time frame: day 3). 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 24 Sep 2010; AzTrials last refreshed its copy on 7 Nov 2026.