Hemorrhoids Clinical Trials

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Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 associated with external congestion.

• Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.

• Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).

• Ability to understand the informed consent.

• Signed informed consent.

Locations
Other Locations
Italy
Azienda Ospedaliera Antonio Cardarelli, Napoli
RECRUITING
Naples
Contact Information
Primary
Antonio Brillantino, MD, PhD
antonio.brillantino@gmail.com
+393290119127
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2026-05-02
Participants
Target number of participants: 80
Treatments
Patients with acute, uncomplicated hemorrhoidal disease
80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria.
Related Therapeutic Areas
Sponsors
Collaborators: Neopharmed Gentili S.p.A.
Leads: Cardarelli Hospital

This content was sourced from clinicaltrials.gov