ocal application of mitomicin C for the treatment of stricturing Crohn?s disease: a phase III, single-center, randomized clinical trial - ND

• Conditions: MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disorders; Stricturing Crohn?s disease

• Registration Number: EUCTR2008-002246-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified