Efficacy and tolerability of a 0.25%glyceryl trinitrate ointment in the treatment of chronic rectal fissures.A multicentric, randomised, open study,controlled vs. Antrolin cream. - ND
- Conditions
- chronic anal fissuresMedDRA version: 9.1Level: LLTClassification code 10002153Term: Anal fissure
- Registration Number
- EUCTR2007-002656-42-IT
- Lead Sponsor
- SOFAR SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
age ≥ 18 e ≤ 60 years
patients suffering for chronic anal fissures with symptoms since 8 weeks
written consent
compliance to study protocol rules
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
patients with atypical anal fissures
acute anal fissures
allergy to the study drugs
patients with IBD
patients with HIV or STD
previous anorectal surgery
previous or actual radiotherapy
pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method