Stricturing Crohn?s disease MedDRA version: 9.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders
Conditions
Interventions
Product Name: Mitomycin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Mitomycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Ph
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years 2. Diagnosis of ileal and/or colonic Crohn?s disease 3. Endoscopic evidence of intestinal stricture 4. Symptoms of stricturing Crohn?s disease 5. Signed informed consent 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active infections 2. Toxic megacolon 3. Bowel perforation 4. Mental disorders precluding giving valid informed consent 5. Active neoplasias 6. Pancitopenia, cardiac, lung, renal serious disease or any other serious active disease 7. Pregnancy or not adequate contraception methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibiliy, toxicity and effectiveness of local application of mitomicin C in the treatment of stricturing Crohn?s disease;Secondary Objective: not available;Primary end point(s): 1) patients? rate with endoscopic or surgical treatment avoided at 3 and 12 months 2) latency to repeated endoscopic or rescue surgical treatment | — |
Countries
Italy
Outcome results
None listed