Status:
UNKNOWN
Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Servier Affaires Médicales
Conditions:
Proctitis Radiation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings
Detailed Description
Radiation proctitis is an inflammation of rectal mucosa, a complication following radiation therapy for cancers of the prostate, cervix, uterus, bladder and other malignancies in the pelvic area. Arou...
Eligibility Criteria
Inclusion
- signed informed consent form
- male and female patients
- age ≥ 18 years
- patients with diagnosis of radiation proctitis with macroscopic bleeding
- end of radiotherapy ≥ 3 month = 90 days ago
Exclusion
- infectious proctitis
- ulcerative proctitis (inflammatory bowel disease)
- persons unable to understand the informed consent
- persons, who are in dependent relationship with the study investigators or Sponsor
- pregnant or lactating women
- participation in an interventional study
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04335617
Start Date
February 26 2020
End Date
August 26 2023
Last Update
November 3 2020
Active Locations (11)
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1
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, 6020
2
Krankenhaus der Stadt Dornbirn
Dornbirn, Austria, 6850
3
Barmherzige Brüder Krankenhaus Graz
Graz, Austria, 8020
4
Medizinische Universität Graz
Graz, Austria, 8036