Peptic UlcerPhase 4NCT02536989
Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot
A Phase 4 study testing omeprazole in people with Peptic Ulcer and Hemorrhage, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peptic Ulcer, Hemorrhage
- What is being tested?
- omeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Jul 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe).
Who cannot join
- ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer.
The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
Read the detailed description
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators will record the basic data of these patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases; clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart rate at the same time, shock status, transfusion amount before allocation; endoscopic findings including the location \& size of ulcer, size of clot, existence of fresh blood in stomach or duodenum. The investigators will monitor the events of rebleeding during admission and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the amount of transfusion and hospitalization days after allocation. When rebleeding is suspected , those patient will receive endoscopic examination and appropriate therapy. Further treatment with surgical or angiographic intervention is decided by the attending physicians.These patients will be monitored during admission (2 weeks in average)and then followed up in GI outpatient clinics.
The investigators define rebleeding during admission and within 30 days as primary end points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The investigators define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
- Conditions
- Peptic Ulcer, Hemorrhage
- Being tested
- omeprazole
- Keywords
- peptic ulcer bleeding, blood clot, dose
- Medical subject headings
- Peptic Ulcer, Hemorrhage, Peptic Ulcer Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazoleDrug
Also called Losec, iv, high dose
receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
omeprazoleDrug
Also called Losec, iv, usual dose
receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days Receives: Drug: omeprazole |
| 2 | Active comparator | receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days Receives: Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding rate within 30 days after allocation
Measured: within 30 days after allocation
Secondary outcomes (1)
blood transfusion units needed within 30 days after allocation
Measured: within 30 days after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Peptic 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzong-Hsi Lee, Far Eastern Memorial Hospital
- Investigators
- Tzong-Hsi Lee, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536989
- Sponsor's protocol ID
- FEMH-96-C009
- Status last verified
- Aug 2010
- First submitted
- 6 Feb 2009
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martins NB, Wassef W. Upper gastrointestinal bleeding. Curr Opin Gastroenterol. 2006 Nov;22(6):612-9. doi: 10.1097/01.mog.0000245542.95408.5d.
PubMed 17053438Rollhauser C, Fleischer DE. Nonvariceal upper gastrointestinal bleeding. Endoscopy. 2004 Jan;36(1):52-8. doi: 10.1055/s-2004-814114.
PubMed 14722856Jung HK, Son HY, Jung SA, Yi SY, Yoo K, Kim DY, Moon IH, Lee HC. Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots. Am J Gastroenterol. 2002 Jul;97(7):1736-40. doi: 10.1111/j.1572-0241.2002.05780.x.
PubMed 12135028Bleau BL, Gostout CJ, Sherman KE, Shaw MJ, Harford WV, Keate RF, Bracy WP, Fleischer DE. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc. 2002 Jul;56(1):1-6. doi: 10.1067/mge.2002.125365.
PubMed 12085028Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC. The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med. 2003 Aug 19;139(4):237-43. doi: 10.7326/0003-4819-139-4-200308190-00005.
PubMed 12965978Sheu BS, Chi CH, Huang CC, Kao AW, Wang YL, Yang HB. Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2002 Jan;16(1):137-43. doi: 10.1046/j.1365-2036.2002.01137.x.
PubMed 11856088Lin HJ, Lo WC, Cheng YC, Perng CL. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Am J Gastroenterol. 2006 Mar;101(3):500-5. doi: 10.1111/j.1572-0241.2006.00399.x.
PubMed 16542286Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.
PubMed 17442905Swain CP, Kirkham JS, Salmon PR, Bown SG, Northfield TC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet. 1986 May 17;1(8490):1113-7. doi: 10.1016/s0140-6736(86)91835-0.
PubMed 2871378Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G, Imperiale TF. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 2005 Sep;129(3):855-62. doi: 10.1053/j.gastro.2005.06.070.
PubMed 16143125Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. doi: 10.1053/gast.2002.34782.
PubMed 12145792Laine L, Freeman M, Cohen H. Lack of uniformity in evaluation of endoscopic prognostic features of bleeding ulcers. Gastrointest Endosc. 1994 Jul-Aug;40(4):411-7. doi: 10.1016/s0016-5107(94)70202-0.
PubMed 7926529Lau JY, Sung JJ, Chan AC, Lai GW, Lau JT, Ng EK, Chung SC, Li AK. Stigmata of hemorrhage in bleeding peptic ulcers: an interobserver agreement study among international experts. Gastrointest Endosc. 1997 Jul;46(1):33-6. doi: 10.1016/s0016-5107(97)70206-2.
PubMed 9260702Swain CP, Storey DW, Bown SG, Heath J, Mills TN, Salmon PR, Northfield TC, Kirkham JS, O'Sullivan JP. Nature of the bleeding vessel in recurrently bleeding gastric ulcers. Gastroenterology. 1986 Mar;90(3):595-608. doi: 10.1016/0016-5085(86)91113-3.
PubMed 3943691Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. doi: 10.1056/NEJM199409153311107. No abstract available.
PubMed 8058080
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
- ClinicalTrials.gov ID
- NCT02536989
- Acronym / sponsor ID
- FEMH-96-C009
- Conditions
- Peptic Ulcer, Hemorrhage
- Keywords
- peptic ulcer bleeding, blood clot, dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Sep 2015 (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 investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer.
The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
Detailed description
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators will record the basic data of these patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases; clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart rate at the same time, shock status, transfusion amount before allocation; endoscopic findings including the location \& size of ulcer, size of clot, existence of fresh blood in stomach or duodenum. The investigators will monitor the events of rebleeding during admission and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the amount of transfusion and hospitalization days after allocation. When rebleeding is suspected , those patient will receive endoscopic examination and appropriate therapy. Further treatment with surgical or angiographic intervention is decided by the attending physicians.These patients will be monitored during admission (2 weeks in average)and then followed up in GI outpatient clinics.
The investigators define rebleeding during admission and within 30 days as primary end points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The investigators define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: omeprazolereceive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days |
| 2 | Active comparator | Drug: omeprazolereceive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe).
Key exclusion criteria (1 listed)
- ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole
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 |
|---|---|---|
| omeprazoleAlso: Losec, iv, high dosereceive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days | Drug | 1 |
| omeprazoleAlso: Losec, iv, usual dosereceive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days | Drug | 2 |
Primary outcome
rebleeding rate within 30 days after allocation
Time frame: within 30 days after allocation
1 secondary outcome
blood transfusion units needed within 30 days after allocation
Time frame: within 30 days after allocation
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 8 Feb 2016.
- Background: PubMed 17053438Martins NB, Wassef W. Upper gastrointestinal bleeding. Curr Opin Gastroenterol. 2006 Nov;22(6):612-9. doi: 10.1097/01.mog.0000245542.95408.5d.
- Background: PubMed 14722856Rollhauser C, Fleischer DE. Nonvariceal upper gastrointestinal bleeding. Endoscopy. 2004 Jan;36(1):52-8. doi: 10.1055/s-2004-814114.
- Background: PubMed 12135028Jung HK, Son HY, Jung SA, Yi SY, Yoo K, Kim DY, Moon IH, Lee HC. Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots. Am J Gastroenterol. 2002 Jul;97(7):1736-40. doi: 10.1111/j.1572-0241.2002.05780.x.
- Background: PubMed 12085028Bleau BL, Gostout CJ, Sherman KE, Shaw MJ, Harford WV, Keate RF, Bracy WP, Fleischer DE. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc. 2002 Jul;56(1):1-6. doi: 10.1067/mge.2002.125365.
- Background: PubMed 12965978Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC. The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med. 2003 Aug 19;139(4):237-43. doi: 10.7326/0003-4819-139-4-200308190-00005.
- Background: PubMed 11856088Sheu BS, Chi CH, Huang CC, Kao AW, Wang YL, Yang HB. Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2002 Jan;16(1):137-43. doi: 10.1046/j.1365-2036.2002.01137.x.
- Background: PubMed 16542286Lin HJ, Lo WC, Cheng YC, Perng CL. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Am J Gastroenterol. 2006 Mar;101(3):500-5. doi: 10.1111/j.1572-0241.2006.00399.x.
- Background: PubMed 17442905Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. doi: 10.1056/NEJMoa065703.
- Background: PubMed 2871378Swain CP, Kirkham JS, Salmon PR, Bown SG, Northfield TC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet. 1986 May 17;1(8490):1113-7. doi: 10.1016/s0140-6736(86)91835-0.
- Background: PubMed 16143125Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G, Imperiale TF. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 2005 Sep;129(3):855-62. doi: 10.1053/j.gastro.2005.06.070.
- Background: PubMed 12145792Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. doi: 10.1053/gast.2002.34782.
- Background: PubMed 7926529Laine L, Freeman M, Cohen H. Lack of uniformity in evaluation of endoscopic prognostic features of bleeding ulcers. Gastrointest Endosc. 1994 Jul-Aug;40(4):411-7. doi: 10.1016/s0016-5107(94)70202-0.
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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.
Tzong-Hsi Lee, M.D. principal investigator
Far Eastern Memorial Hospital
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 omeprazole in people with Peptic Ulcer and Hemorrhage, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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 8 Feb 2016. 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 Taiwan. 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?
rebleeding rate within 30 days after allocation (time frame: within 30 days after allocation). 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 NCT02536989, which also lists 17 linked publications.
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 8 Feb 2016.