Anal fissures Digestive System
Conditions
Interventions
Participants fulfilling the inclusion criteria will be recruited by GP doctors or gastroenterologists. After signing the Informed Consent Form each participant will be evaluated for inclusion/exclusio
Sponsors
Noventure S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of ULKOX® OLE will be evaluated by measuring time to complete healing – subjective evaluation through the patient journal on a daily basis for the first 7 days of the treatment phase (Bleeding Present/Absent), and then on a weekly basis until treatment end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness will be evaluated through: 1. Proportion of patients that experienced bleeding disappearance from Baseline to EOT (Day 42) 2. Time to pain reduction evaluated by a VAS scale from 1-10 - through the patient journal on a daily basis for the first 7 days of the treatment phase, and then on a weekly basis until treatment end. 3. Time to discomfort level reduction evaluated by a daily 7-point Likert scale (1 – Totally unacceptable, 2 – Unacceptable, 3 – Slightly unacceptable, 4 – Neutral, 5 – Slightly acceptable, 6 – Acceptable, 7 – Perfectly Acceptable) - through the patient journal on a weekly basis during the treatment phase (day 42) 4. Patient quality of life evaluated using SF-36 from baseline to visit 3 - EOT (Day 42) Safety will be evaluated by: 1. Proportion of patients that experience adverse events (AEs) during the study period 2. Patients’ participation withdrawal due to AE occurrence during the study period | — |
Countries
Bulgaria, Romania
Contacts
Public ContactAlina Iordache
Outcome results
None listed