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

NCT ID: NCT04335617

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2023-08-26

Brief Summary

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

Detailed Description

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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. Around 20 % of radiation patients develop radiation proctitis. There is a significant lack of trial treatments for radiation proctitis, even more, the studies often are small and single center designed or case series. In 2 recent reviews pointing out the management of radiation proctitis (2018 and 2016) a summary of current options in therapy according to current scientific knowledge is given. Unfortunately, these studies are about interventional options with the serious risk of complication. Only little data and lack of significance in smaller series on conservative strategies are given.

The goal of the trial is to implement a specific medication in the management and every grade of radiation proctitis - concomitant to eventual need of MMPF is described with potent anti-inflammatory mucosal capacity reducing bleeding, pain and urgency symptoms in patients with hemorrhoidal and/or postoperative symptoms. By using a placebo instead of comparative oral medications (with low evidence) this study might illustrate clinical significance of expected results as well as information on the natural history of radiation proctitis.

The goal of the study is to compare the number of necessary interventions required to stop bleeding in chronic radiation proctitis in patients receiving MMPF in comparison to patients in the control group receiving Placebo within 12 months of medical treatment.

Conditions

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Proctitis Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Investigational

Patients receive MMPF 500mg for one year

Group Type EXPERIMENTAL

MMPF (Micronized purified Flavonoid-Fraction)

Intervention Type 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

Placebo

Patients receive Placebo for one year

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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MMPF (Micronized purified Flavonoid-Fraction)

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier Affaires Médicales

INDUSTRY

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Irmgard E Kronberger, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medizinische Universität Innsbruck

Innsbruck, Tyrol, Austria

Site Status RECRUITING

Krankenhaus der Stadt Dornbirn

Dornbirn, , Austria

Site Status NOT_YET_RECRUITING

Barmherzige Brüder Krankenhaus Graz

Graz, , Austria

Site Status RECRUITING

Medizinische Universität Graz

Graz, , Austria

Site Status RECRUITING

Universitätsklinikum Krems

Krems, , Austria

Site Status RECRUITING

Ordensklinikum Linz GmbH Elisabethinen

Linz, , Austria

Site Status RECRUITING

Kepleruniversität Linz

Linz, , Austria

Site Status RECRUITING

Universitätsklinikum Tulln

Tulln, , Austria

Site Status RECRUITING

Medizinische Universität Wien

Vienna, , Austria

Site Status RECRUITING

Krankenhaus Nord, Klinik Floridsdorf

Vienna, , Austria

Site Status RECRUITING

Salzkammergut Klinikum Vöcklabruck

Vöcklabruck, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Irmgard Kronberger, MD

Role: CONTACT

[email protected]
+43 512 504 ext. 0

Marijana Ninkovic, MD

Role: CONTACT

[email protected]
+43 512 504 ext. 0

Facility Contacts

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Irmgard E Kronberger, MD

Role: primary

[email protected]

Clemens Obwegeser, Dr.

Role: primary

Martin Mitteregger, Dr.

Role: primary

Martina Lemmerer, Dr.

Role: primary

Stefan Sattler, Dr.

Role: primary

Ulrike Enkner, Dr.

Role: primary

Günther Klimbacher, Dr.

Role: primary

Alf-Dorian Binder, Dr.

Role: primary

Stefan Riss, Assoc.-Prof.

Role: primary

Zacaria Sow, Dr.

Role: primary

Raimund Strouhal, Dr.

Role: primary

Other Identifiers

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MiFlaPRO_2019

Identifier Type: -

Identifier Source: org_study_id