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

NCT07295886 | Recruiting

• 1 other identifier: Nilos
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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; Topical Administration; Hemorrhoid Bleeding; Hemorrhoids Prolapse; Hemorrhoid Pain

Keywords

nifedipine 0.3% plus lidocaine 1.5%; uncomplicated hemorrhoidal disease; hemorrhoids symptoms

Outcome Measures

Primary Outcomes (1)

• Change in HDSS (hemorrhoidal disease symptom score) questionnaire, analyzed using paired t-test or Wilcoxon signed-rank test according to data distribution. The total HDSS ranges from 0 to 20, with higher scores indicating greater symptom severity.

  From enrollment to the 30-day follow-up

Secondary Outcomes (3)

• Quality of life related to hemorrhoidal disease

  From baseline to 30 day follow-up

• Hemorroidal Pain

  From baseline to 30 day follow-up

• Hemorrhoidal prolapse down-staging

  From baseline to 30 day follow-up

Study Arms (1)

Patients with acute, uncomplicated hemorrhoidal disease

80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria.

Drug: topical nifedipine 0.3% plus lidocaine 1.5%

Interventions

topical nifedipine 0.3% plus lidocaine 1.5% DRUG

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

Patients with acute, uncomplicated hemorrhoidal disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• Acute hemorrhoidal disease complicated by thrombosis or strangulation.
• Coagulopathies.
• Active neoplastic disease.
• Treatment with anticoagulants and/or chemotherapeutic agents.
• Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.
• Severe hypotensive states or cardiovascular insufficiency.
• Pregnancy or breastfeeding.
• Participation in clinical trials involving investigational drugs.

Sponsors & Collaborators

• Cardarelli Hospital: lead
• Neopharmed Gentili S.p.A.: collaborator

Study Sites (1)

Azienda Ospedaliera "Antonio Cardarelli", Napoli

Naples, 80131, Italy

RECRUITING

Related Publications (8)

• Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.

  PMID: 30451751 RESULT

• Brillantino A, Renzi A, Talento P, Brusciano L, Marano L, Grillo M, Maglio MN, Foroni F, Palumbo A, Sotelo MLS, Vicenzo L, Lanza M, Frezza G, Antropoli M, Gambardella C, Monaco L, Ferrante I, Izzo D, Giordano A, Pinto M, Fantini C, Gasparrini M, Schiano Di Visconte M, Milazzo F, Ferreri G, Braini A, Cocozza U, Pezzatini M, Gianfreda V, Di Leo A, Landolfi V, Favetta U, Agradi S, Marino G, Varriale M, Mongardini M, Pagano CEFA, Contul RB, Gallese N, Ucchino G, D'Ambra M, Rizzato R, Sarzo G, Masci B, Da Pozzo F, Ascanelli S, Liguori P, Pezzolla A, Iacobellis F, Boriani E, Cudazzo E, Babic F, Geremia C, Bussotti A, Cicconi M, Sarno AD, Mongardini FM, Brescia A, Lenisa L, Mistrangelo M, Zuin M, Mozzon M, Chiriatti AP, Bottino V, Ferronetti A, Rispoli C, Carbone L, Calabro G, Tirro A, de Vito D, Ioia G, Lamanna GL, Asciore L, Greco E, Bianchi P, D'Oriano G, Stazi A, Antonacci N, Renzo RMD, Poto GE, Ferulano GP, Longo A, Docimo L. The Italian Unitary Society of Colon-Proctology (Societa Italiana Unitaria di Colonproctologia) guidelines for the management of acute and chronic hemorrhoidal disease. Ann Coloproctol. 2024 Aug;40(4):287-320. doi: 10.3393/ac.2023.00871.0124. Epub 2024 Aug 30.

  PMID: 39228195 RESULT

• Tarasconi A, Perrone G, Davies J, Coimbra R, Moore E, Azzaroli F, Abongwa H, De Simone B, Gallo G, Rossi G, Abu-Zidan F, Agnoletti V, de'Angelis G, de'Angelis N, Ansaloni L, Baiocchi GL, Carcoforo P, Ceresoli M, Chichom-Mefire A, Di Saverio S, Gaiani F, Giuffrida M, Hecker A, Inaba K, Kelly M, Kirkpatrick A, Kluger Y, Leppaniemi A, Litvin A, Ordonez C, Pattonieri V, Peitzman A, Pikoulis M, Sakakushev B, Sartelli M, Shelat V, Tan E, Testini M, Velmahos G, Wani I, Weber D, Biffl W, Coccolini F, Catena F. Anorectal emergencies: WSES-AAST guidelines. World J Emerg Surg. 2021 Sep 16;16(1):48. doi: 10.1186/s13017-021-00384-x.

  PMID: 34530908 RESULT

• Antropoli C, Perrotti P, Rubino M, Martino A, De Stefano G, Migliore G, Antropoli M, Piazza P. Nifedipine for local use in conservative treatment of anal fissures: preliminary results of a multicenter study. Dis Colon Rectum. 1999 Aug;42(8):1011-5. doi: 10.1007/BF02236693.

  PMID: 10458123 RESULT

• Perrotti P, Bove A, Antropoli C, Molino D, Antropoli M, Balzano A, De Stefano G, Attena F. Topical nifedipine with lidocaine ointment vs. active control for treatment of chronic anal fissure: results of a prospective, randomized, double-blind study. Dis Colon Rectum. 2002 Nov;45(11):1468-75. doi: 10.1007/s10350-004-6452-1.

  PMID: 12432293 RESULT

• Perrotti P, Antropoli C, Molino D, De Stefano G, Antropoli M. Conservative treatment of acute thrombosed external hemorrhoids with topical nifedipine. Dis Colon Rectum. 2001 Mar;44(3):405-9. doi: 10.1007/BF02234741.

  PMID: 11289288 RESULT

• Thomson WH. The nature of haemorrhoids. Br J Surg. 1975 Jul;62(7):542-52. doi: 10.1002/bjs.1800620710.

  PMID: 1174785 RESULT

• GASS OC, ADAMS J. Hemorrhoids; etiology and pathology. Am J Surg. 1950 Jan;79(1):40-3. doi: 10.1016/0002-9610(50)90189-9. No abstract available.

  PMID: 15399351 RESULT

MeSH Terms

Conditions

Hemorrhoids

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Antonio Brillantino, MD, PhD

CONTACT

+393290119127; antonio.brillantino@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: September 2, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)