chronic anal fissures MedDRA version: 9.1 Level: LLT Classification code 10002153 Term: Anal fissure
Conditions
Interventions
Product Name: Glyceryl trinitrate
Pharmaceutical Form: Rectal ointment
INN or Proposed INN: GLYCERYL TRINITRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the equivalence between a 0.25%glyceryl trinitrate ointment and Antrolin cream in the treatment of chronic rectal fissures.;Secondary Objective: - to evaluate sphincterial tone - to reduce surgery (left lateral sphinterotomy) and fecal incontinence evaluation af adverse events;Primary end point(s): to evaluate the equivalence between a 0.25%glyceryl trinitrate ointment and Antrolin cream in the treatment of chronic rectal fissures. | — |
Countries
Italy
Outcome results
None listed