Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis

• Status: Recruiting
• Trial end date: 2023-08-26
• Target enrollment: 0
• Participant gender: All

Summary

national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck
• Collaborator: Servier Affaires Médicales

Criteria

Inclusion Criteria:

• 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 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 or Sponsor

• pregnant or lactating women

• participation in an interventional study