botulinum toxin for the treatment of chronic anal fissure
- Conditions
- Chronic anal fissureTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2017-001216-11-ES
- Lead Sponsor
- Dra. A. Teresa Calderón Duque
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
* Patients seen in the clinical Surgery Consultation with diagnosis of chronic anal fissure.
* Patients older than 18 years of age with a diagnostic of fissure of more than two months of evolution who have not responded to previous anal fissure medical treatments. Medical treatment would consist of hygienic dietary measures and systemic and local analgesic treatment with ointments (Annex 1). These ointments will be either calcium antagonists (Diltiazem 2%) or nitrates (Rectogesic 0.4%), whose main function is to relax the smooth muscle of the anus. This treatment should be prescribed for 6-8 weeks before assessing whether or not there has been healing or improvement
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
*Minors
*Patients with diagnosis of chronic anal fissure that it isn’t idiopathic.
* Patients who have not previously received medical treatment for the anal fissure.
* Patients with contraindication to the use of Botulinum Toxin type A: Myasthenia gravis, Eaton-Lambert syndrome, pregnant women, acelticoline deficiency.
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