Open-label, multicenter clinical study to evaluate the safety and efficacy of ULKOX® OLE vs SoC (e.g., cicatridinum ointment, ointment for anal fissures) in adult patients diagnosed with anal fissures

Not Applicable

Completed

• Conditions: Anal fissures; Digestive System

• Registration Number: ISRCTN40732544
• Lead Sponsor: oventure S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-23
• Study Start: 2024-01-31
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Adult patients (aged >18 years)
2. Patients diagnosed with acute anal fissures or chronic anal fissures, with an acute episode
3. Treatment prescription decision (ULKOX® OLE or SoC) before participation invitation into the study
4. Willing to sign the Informed Consent form for data collecting and processing

Exclusion Criteria

1. Unwillingness to provide signed Informed Consent for data collecting
2. Other medical condition that does not allow participation in this study (e.g., immunodeficiency patients, patients that are administering blood pressure medication that can determine relax the anal sphincter – e.g., calcium channel blockers)
3. Patients that receive as Standard of Care a drug treatment
4. Pregnancy and breastfeeding patients
5. Administration of medication/treatments that could have the same effect as the study proposed treatment (e.g., nitroglycerin, lidocaine hydrochloride, botulinum toxin, nifedipine, diltiazem)
6. Hypersensitivity or individual allergy to one or more components of the product

Study & Design

• Study Type: Interventional
• Study Design: Not specified