A randomised, double-blind, parallel-group, placebo controlled study ofesomeprazole i.v. (bolus infusion of 80 mg followed by a continuous infusionof 8 mg per hour) administered for 72 hours to assess prevention ofrebleeding in subjects that have undergone successful primary endoscopichaemostasis of a bleeding peptic ulcer – the PUB study - NA
- Conditions
- Gatrointestinal haemorrhages NEC. (Bleeding gastric or duodenal ulcer will be investigated).MedDRA classification code Level: HLGT = High Level Group Term. See below.MedDRA version: 8.0Level: HLGTClassification code 10017959
- Registration Number
- EUCTR2005-002441-39-NO
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 760
For inclusion in the study, subjects must fulfil all of the following criteria:
1.Provision of informed consent.
2.Female or male aged 18 years and over.
3.Upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or with such sign within the last 24 hours as judged by the investigator.
4.One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding is required.
Forrest classification of PUB (Forrest et al 1974):
Ia = arterial bleeding
Ib = oozing bleeding
IIa = non-bleeding visible vessel
IIb = adherent clot
In case of Forrest IIb (adherent clot), all efforts should be made to remove the clot. If the clot cannot be removed, it is to be handled as follows:
-If the clot can be removed with 5 min of high-pressure water irrigation (Laine et al 1996) or by cold snare, the ulcer should be reclassified and only Forrest Ia, Ib and IIa should be included.
-If the clot cannot be removed despite these measures, the subject should be included as Forrest IIb.
5.Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment with:
-Injection therapy (epinephrine, dilution 1:10000)
and/or one of the following:
-Coagulation with heater probe
-Electrocautery
-Haemoclips.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Any of the following is regarded as a criterion for exclusion from the study:
1.Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
2.The ASA classification (Appendix C) of physical status > 3 as judged by the investigator.
3.Severe hepatic disease defined as Child-Pugh B or C (Appendix D).
4.Severe renal disease, defined as subject requiring dialysis or subject in imminent need of dialysis as judged by the investigator.
5.Major cardiovascular event at enrolment or within 3 months prior to study start, such as stroke, myocardial infarction, or hospitalisation for treatment of unstable angina pectoris as judged by the investigator.
6.Haemorrhagic disorder, platelets <100x10e9/L, INR>1.5, APTT>1.5x upper limit of normal (ULN), or treatment with low-molecular weight heparin.
7.Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
8.Sign of multiple bleeding peptic ulcers or concomitant other gastrointestinal bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy’s lesion, colon, small bowel, or ulcer distal to the stoma in Billroth-resected subjects.
9.Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) and clopidogrel.
10.Known or suspected hypersensitivity to any component of any PPI (esomeprazole, omeprazole, lansoprazole, rabeprazole, or pantoprazole).
11.Planned treatment with medication that could interact with esomeprazole; ie, phenytoin, clarithromycin, itraconazole, ketoconazole, warfarin (including other vitamin K antagonists), cisapride, atazanavir and ritonavir.
12.Chemotherapy or radiation therapies within 2 weeks prior to study start or planned during the course of the study.
13.Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
14.Known or suspected alcohol, drug or medication abuse, or any condition associated with poor compliance as judged by the investigator.
15.Participation in any study of investigational drugs within the preceding 30 days prior to enrolment.
16.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
17.Previous enrolment in the present study.
18. Intravenous administrationof a PPI (esomeprazole, omeprazole, lansoprazole, rabeprazole or pantoprazole) exceeding a total dose of 40 mg within 24 hours prior to enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method