Comparative clinical study to evaluate the safety and utility of ULKOX® OLE in relieving the clinical symptoms of anal fissures in adult patients

oventure S.L.0 个研究点目标入组 42 人开始时间: 2024年1月31日最近更新: 2024年2月12日

试验速览

暂无简介。

•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

•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

发起方

oventure S.L.