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

NCT07295886 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Hemorrhoid Bleeding
  • Hemorrhoids Prolapse
  • Hemorrhoid Pain
  • Hemorrhoid
  • Topical Administration

Interventions

DRUG

topical nifedipine 0.3% plus lidocaine 1.5%

Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease

Sponsors & Collaborators

  • Neopharmed Gentili S.p.A.

    collaborator INDUSTRY

  • Cardarelli Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2026-05-02
Completion
2026-05-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295886 on ClinicalTrials.gov