Clinical Trial

Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease

Study acronym: NILOS
Recruiting
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Record status
This record was last updated December 22, 2025 (before its estimated May 2, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is: Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.
Trial Details
NCT Number NCT07295886
Lead Sponsor Cardarelli Hospital
Collaborators: Neopharmed Gentili S.p.A.
Conditions Hemorrhoid Bleeding, Hemorrhoids Prolapse, Hemorrhoid Pain, Hemorrhoid, Topical Administration
Enrollment 80 participants
Start Date 2025-09-02
Primary Completion 2026-05-02 (estimated)
Study Completion 2026-05-02 (estimated)
Updated on ClinicalTrials.gov 2025-12-22