drugset / Trial / NCT00827736

Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

NCT00827736

Phase 4 Completed 73 enrolled Onze Lieve Vrouwe Gasthuis
RandomizedParallel-groupTriple-blindTreatment

Summary

The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.

Timeline

Start
2002-06
Primary completion
2006-03
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isosorbide Dinitrate Other / unclassified 1 % Topical