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.

INTERVENTION: 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‐ Trade Name: ANTROLIN Pharmaceutical Form: Rectal cream INN or Proposed INN: NIFEDIPINE CAS Number: 21829‐25‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9‐ INN or Proposed INN: LIDOCAINA CLORIDRATO CAS Number: 73‐78‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9‐ CONDITION: chronic anal fissures ; MedDRA version: 9.1 Level: LLT Classification code 10002153 Term: Anal fissure PRIMARY OUTCOME: Main Objective: to evaluate the equivalence between a 0.25%glyceryl trinitrate ointment and Antrolin cream in the treatment of chronic rectal fissures. 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. Secondary Objective: ‐ to evaluate sphincterial tone; ‐ to reduce surgery (left lateral sphinterotomy) and fecal incontinence; evaluation af adverse events 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