Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07295886

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

Led by Cardarelli Hospital · Updated on 2025-12-22

80

Participants Needed

1

Research Sites

N/A

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

This research aims to evaluate the effectiveness of a topical cream containing nifedipine 0.3% and lidocaine 1.5% for treating patients with uncomplicated acute hemorrhoidal disease. The main question is whether this treatment can reduce symptoms in patients with this condition. The study is observational and focuses on patients already using this cream as part of their regular care. Participants will apply the topical nifedipine 0.3% plus lidocaine 1.5% cream both rectally and perianally twice daily for at least 21 days. The study involves four assessments over about 30 days: a baseline visit within five days of starting treatment, a telephone contact at day 10, an in-person visit at day 21, and a final telephone contact at day 30. The study plans to enroll 80 patients. During the study, participants will complete symptom questionnaires including the Hemorrhoidal Disease Symptom Score (HDSS) and assessments of quality of life, pain, and hemorrhoidal prolapse. Data will be collected and analyzed to understand symptom changes and treatment impact. The primary outcome is the change in HDSS over 30 days. The study includes monitoring of symptoms and quality of life throughout the 30-day observation period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 to 75 years
  • Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly with external congestion
  • Started treatment with nifedipine 0.3% plus lidocaine 1.5% within the past 5 days
  • Availability of clinical evaluations at treatment start (proctologic visit and symptom scales)
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Acute hemorrhoidal disease complicated by thrombosis or strangulation
  • Coagulopathies (blood clotting disorders)
  • Active cancer
  • Treatment with anticoagulants or chemotherapy
  • Allergy to lidocaine, similar local anesthetics, or cream ingredients
  • Severe low blood pressure or heart failure
  • Pregnancy or breastfeeding
  • Participation in other clinical trials involving investigational drugs

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At least 21 days

Participants apply topical nifedipine 0.3% plus lidocaine 1.5% cream rectally and perianally twice daily for at least 21 days.

1 baseline visit, 1 in-person visit at day 21, and 2 telephone contacts at days 10 and 30

Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera "Antonio Cardarelli", Napoli

Naples, Italy, 80131

Actively Recruiting

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Research Team

A

Antonio Brillantino, MD, PhD

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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Published Research Related To This Trial

Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease.

Håvard D Rørvik, Karl Styr, Lars Ilum...

https://pubmed.ncbi.nlm.nih.gov/30451751

The Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease.

Antonio Brillantino, Adolfo Renzi, Pasquale Talento...

https://pubmed.ncbi.nlm.nih.gov/39228195

Topical nifedipine with lidocaine ointment vs. active control for treatment of chronic anal fissure: results of a prospective, randomized, double-blind study.

Pasquale Perrotti, Antonio Bove, Carmine Antropoli...

https://pubmed.ncbi.nlm.nih.gov/12432293