Peptic UlcerPhase 3IOENCT01142245
Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy
A Phase 3 study testing Oral esomeprazole and Intravenous Esomeprazole in people with Peptic Ulcer and Bleeding, run by Chinese University of Hong Kong at 2 sites in China.
Trial summary
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer, Bleeding
- What is being tested?
- Oral esomeprazole and Intravenous Esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2008to Jul 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb
- Endoscopic hemostasis achieved
- Informed consent obtained
Who cannot join
- No consent
- Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding)
- Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated
- Moribund patients in whom active treatment of any form is not considered.
- Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation
- Upper GI malignancy or disseminated malignant disease
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- Esophageal varices
- A Mallory-Weiss lesion
- Phenytoin or theophylline treatment
- Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Endoscopy Centre
Hong Kong, 852
Endoscopy Center in Prince of Wales Hospital
Hong Kong (sar)
About this study
Official title: Phase 3 Study of Effect of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy (IOE Study)
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.
The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.
Read the detailed description
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.
Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification. Patients with a clean ulcer base have a < 5% risk of rebleeding; this increases progressively with a flat spot, adherent clot, non-bleeding visible vessel and active bleeding (55%). Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use.
- Conditions
- Peptic Ulcer, Bleeding
- Being tested
- Oral esomeprazole, Intravenous Esomeprazole
- Keywords
- ulcer bleeding, endoscopic therapy
- 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.
Oral esomeprazoleDrug
Also called oral, nexium
- Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h
Intravenous EsomeprazoleDrug
Also called IV, nexium
Esomeprazole IV 80mg loading bolus
- Esomeprazole intravenous infusion 8mg/hr for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| oral esomeprazole | Active comparator | * Esomeprazole placebo IV loading bolus
* Esomeprazole placebo intravenous infusion for 72 hours
* Oral Esomeprazole: 80 mg/Day on Day 1, 2 and Day 3, and the drug will be given as 40 mg q12h. Receives: Drug: Oral esomeprazole |
| Intravenous Esomeprazole | Active comparator | Esomeprazole IV loading bolus 80mg
• Esomeprazole intravenous infusion 8mg/hr for 72 hours Receives: Drug: Intravenous Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical rebleeding within 30 day of endoscopic therapy
Definition of clinical rebleeding
- Recurrent hematemesis
- fresh melena after normal stool
- Hypotension SBP<90 or tachycardia >110 AND fresh melena
- Decrease in Hb >2g/dL (or Hct > 10%) during any 24 h or an increas in Hb <1 g/dL (or Hct <3%) despite ≥4 units of blood has been transfused during any 48h
Measured: 30 days
Secondary outcomes (7)
Un-scheduled further endoscopic therapy
- Un-scheduled further endoscopic therapy
- Need for surgery (i.e., operation rate)
- Duration of hospitalization
- Blood transfusion
Measured: 30 days
Need for surgery
Measured: 30 days
Duration of hospitalization
Measured: 30 days
Blood transfusion
Measured: 30 days
mortality
Measured: 30 days
need of surgery
Measured: 30 days
un-scheduled further endoscopic therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
- Investigators
- Francis K Chan, MD, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142245
- Sponsor's protocol ID
- IOE
- Acronym
- IOE
- Status last verified
- Aug 2015
- First submitted
- 9 Jun 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Effect of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy (IOE Study)
- ClinicalTrials.gov ID
- NCT01142245
- Acronym / sponsor ID
- IOE / IOE
- Conditions
- Peptic Ulcer, Bleeding
- Keywords
- ulcer bleeding, endoscopic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jun 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.
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.
The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.
Detailed description
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.
Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification. Patients with a clean ulcer base have a < 5% risk of rebleeding; this increases progressively with a flat spot, adherent clot, non-bleeding visible vessel and active bleeding (55%). Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral esomeprazole | Active comparator | Drug: Oral esomeprazole* Esomeprazole placebo IV loading bolus * Esomeprazole placebo intravenous infusion for 72 hours * Oral Esomeprazole: 80 mg/Day on Day 1, 2 and Day 3, and the drug will be given as 40 mg q12h. |
| Intravenous Esomeprazole | Active comparator | Drug: Intravenous EsomeprazoleEsomeprazole IV loading bolus 80mg • Esomeprazole intravenous infusion 8mg/hr for 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb
- Endoscopic hemostasis achieved
- Informed consent obtained
Key exclusion criteria (10 listed)
- No consent
- Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding)
- Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated
- Moribund patients in whom active treatment of any form is not considered.
- Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation
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 |
|---|---|---|
| Oral esomeprazoleAlso: oral, nexium• Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h | Drug | oral esomeprazole |
| Intravenous EsomeprazoleAlso: IV, nexiumEsomeprazole IV 80mg loading bolus * Esomeprazole intravenous infusion 8mg/hr for 72 hours | Drug | Intravenous Esomeprazole |
Primary outcome
Rate of clinical rebleeding within 30 day of endoscopic therapy
Time frame: 30 days
Definition of clinical rebleeding 1. Recurrent hematemesis 2. fresh melena after normal stool 3. Hypotension SBP<90 or tachycardia >110 AND fresh melena 4. Decrease in Hb >2g/dL (or Hct > 10%) during any 24 h or an increas in Hb <1 g/dL (or Hct <3%) despite ≥4 units of blood has been transfused during any 48h
7 secondary outcomes
Un-scheduled further endoscopic therapy
Time frame: 30 days
Need for surgery
Time frame: 30 days
Duration of hospitalization
Time frame: 30 days
Blood transfusion
Time frame: 30 days
mortality
Time frame: 30 days
need of surgery
Time frame: 30 days
un-scheduled further endoscopic therapy
Time frame: 30 days
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 13 Aug 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.
Francis K Chan, MD principal investigator
CUHK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral esomeprazole and Intravenous Esomeprazole in people with Peptic Ulcer and Bleeding, run by Chinese University of Hong Kong at 2 sites in China.
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 10 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 13 Aug 2015. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of clinical rebleeding within 30 day of endoscopic therapy (time frame: 30 days). 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 13 Aug 2015.