actinic proctitis MedDRA version: 6.1 Level: PT Classification code 10036783
Conditions
Interventions
Trade Name: TOPSTER*10SUPP 3MG
Pharmaceutical Form: Rectal foam
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Rectal foam
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age 8805; 18 and 8804; 75 2. patient with aat least one of the following - patients that will do radiotherapy or brachitherapy for prostate carcinoma -patients that will do adjuvant radiotherapy for prostate carcinoma -patients that will do radiotherapy plus chemotherapy for carcinoma of the cervix -patients that will do adjuvant radiotherapy for carcinoma of the cervix 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patients with digestive pathologies 2.intolerance to beclometasone dipropionate 3. patients with severe pathologies 4. pregnancy or lactation 5. patients with IBD 6. non compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the efficacy of topic beclomethasone dipropionate on the prevention of acute and chronic actinic proctitis;Secondary Objective: evaluation of the efficacy of topic beclomethasone dipropionate on the patient s quality of life;Primary end point(s): evaluation of the efficacy of topic beclomethasone dipropionate on the prevention of acute and chronic actinic proctitis | — |
Countries
Italy
Outcome results
None listed