PPI as an adjunct to endoscopic hemostasis for bleeding peptic ulcer a randomized clinical trial of a high vs a standard regimen for the i.v. drug infusion - PPI for bleeding peptic ulcers
- Conditions
- Patients with peptic ulcer bleedingMedDRA version: 8.1Level: LLTClassification code 10034344Term: Peptic ulcer haemorrhage
- Registration Number
- EUCTR2006-005454-76-IT
- Lead Sponsor
- IRCCS CASA SOLLIEVO DELLA SOFFERENZA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Active peptic ulcer bleeding following a successful endoscopic hemostasis
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
Exclusion Criteria
Peptic ulcers which have stopped to bleed spontaneously
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of a high vs a standard regimen for the i.v. infusion of PPI;Secondary Objective: None;Primary end point(s): Evaluation of chimical efficacy of the two PPI regimens in team of re-bleeding and mortality rates following the index bleeding
- Secondary Outcome Measures
Name Time Method