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Clinical Trials/EUCTR2017-001216-11-ES
EUCTR2017-001216-11-ES
Active, not recruiting
Phase 1

sefulness of botulinum toxin type A in the treatment of chronic anal fissure

Dra. A. Teresa Calderón Duque0 sitesApril 7, 2017

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic anal fissure
Sponsor
Dra. A. Teresa Calderón Duque
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 7, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dra. A. Teresa Calderón Duque

Eligibility Criteria

Inclusion Criteria

  • \* 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

Exclusion Criteria

  • \*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.

Outcomes

Primary Outcomes

Not specified

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