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New cream aims to calm hemorrhoid flare-ups fast

NCT ID NCT07295886

Symptom relief Sponsor: Cardarelli Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study looks at whether a cream containing nifedipine 0.3% and lidocaine 1.5% can reduce symptoms like pain, bleeding, and prolapse in people with acute uncomplicated hemorrhoids. About 80 adults aged 18 to 75 who have already started this cream as part of their care will be followed for 30 days. Researchers will track symptom scores and quality of life to see if the treatment helps.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hemorrhoid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhoid Hemorrhoid bleeding Hemorrhoid pain Hemorrhoids prolapse Topical administration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera "Antonio Cardarelli", Napoli

    RECRUITING

    Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.