Actively Recruiting
Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Led by Cardarelli Hospital · Updated on 2025-12-22
80
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
C
Cardarelli Hospital
Lead Sponsor
N
Neopharmed Gentili S.p.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18-75 years
- Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly with external congestion
- Treatment with nifedipine 0.3% plus lidocaine 1.5% started within the past 5 days
- Availability of clinical evaluations at treatment start including proctologic visit and symptom scoring
- Ability to understand and sign informed consent
You will not qualify if you...
- Acute hemorrhoidal disease complicated by thrombosis or strangulation
- Coagulopathies
- Active cancer
- Treatment with anticoagulants or chemotherapy
- Allergic reaction to lidocaine or similar anesthetics or to excipients
- Severe low blood pressure or heart failure
- Pregnancy or breastfeeding
- Participation in clinical trials with investigational drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera "Antonio Cardarelli", Napoli
Naples, Italy, 80131
Actively Recruiting
Research Team
A
Antonio Brillantino, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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