EUCTR2019-001916-44-ATActive, not recruitingPhase 1
A multicenter, randomized, doubleblind placebo controlled trial ofMicronized purified Flavonoid-Fraction (MPFF) in the managementof radiation proctitis - MiFlaPRO
Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery0 sites200 target enrollmentStarted: January 7, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •signed informed consent form
- •male and female patients
- •age = 18 years
- •patients with diagnosis of radiation proctitis with macroscopic bleeding
- •end of radiotherapiy >= 3 month = 90 days
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •infectious proctitis
- •ulcerative proctitis (inflammatory bowel disease)
- •persons unable to understand the informed consent
- •persons, who are in dependent relationship with the study investigators
- •pregnant or lactating women
- •participation in an interventional study
Investigators
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