NCT04335617

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2020

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2023

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

December 13, 2019

Last Update Submit

October 30, 2020

Conditions

Proctitis Radiation

Outcome Measures

Primary Outcomes (1)

  • Number of necessary intervention

    Interventions to stop acute bleeding by chronic radiation proctitis: surgical, endoscopic or proctoscopic interventions

    Day 1- Day 360

Secondary Outcomes (4)

  • Quality of life of patients

    Day 0 Day 180 Day 360

  • Blood samples

    Day 0-Day 360

  • Stool

    Day 0-Day 360

  • Presence of histological alterations

    Day 0-Day 360

Study Arms (2)

Investigational

EXPERIMENTAL

Patients receive MMPF 500mg for one year

Drug: MMPF (Micronized purified Flavonoid-Fraction)

Placebo

PLACEBO COMPARATOR

Patients receive Placebo for one year

Other: Placebo

Interventions

MMPF (Micronized purified Flavonoid-Fraction)DRUG

500mg film-coated tablet, oral route, tablets should be taken at meal times. 4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily, one at midday and one in the evening

Investigational
PlaceboOTHER

4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Medizinische Universität Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Krankenhaus der Stadt Dornbirn

Dornbirn, 6850, Austria

NOT YET RECRUITING

Barmherzige Brüder Krankenhaus Graz

Graz, 8020, Austria

RECRUITING

Medizinische Universität Graz

Graz, 8036, Austria

RECRUITING

Universitätsklinikum Krems

Krems, 3500, Austria

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020, Austria

RECRUITING

Kepleruniversität Linz

Linz, 4040, Austria

RECRUITING

Universitätsklinikum Tulln

Tulln, 3430, Austria

RECRUITING

Medizinische Universität Wien

Vienna, 1090, Austria

RECRUITING

Krankenhaus Nord, Klinik Floridsdorf

Vienna, 1210, Austria

RECRUITING

Salzkammergut Klinikum Vöcklabruck

Vöcklabruck, 4840, Austria

RECRUITING

Central Study Contacts

Irmgard Kronberger, MD

CONTACT

+43 512 504irmgard.kronberger@i-med.ac.at

Marijana Ninkovic, MD

CONTACT

+43 512 504marijana.ninkovic@i-med.ac.at

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
In this double blinded study Daflon and placebo are packed in the same manner, the blind is also protected by randomization. Only the principal investigator can break the blind in case of ethical or threatening patterns by contacting the sponsor and clinical research item.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 13, 2019

First Posted

April 6, 2020

Study Start

February 26, 2020

Primary Completion

February 26, 2023

Study Completion

August 26, 2023

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

AU(11)