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Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease

NCT05984641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-03

No results posted yet for this study

Summary

Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.

Conditions

  • Hemorrhoid Pain
  • Haemorrhoid Inflammation

Interventions

DEVICE

CONAN® Proctological Cream

The active treatment samples used for the duration of the study were allocated at the site involved and consisted in 30 g tubes with an endorectal applicator, identified by the batch number, expiry date and information on the study on dedicated labels. The treatment of patients randomized to Group A consisted in applying the local treatment (1 application 3 times/day) for 30 days. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

Sponsors & Collaborators

  • Omikron Italia S.r.l.

    lead INDUSTRY

Principal Investigators

  • Nicola Di Lorenzo, Medicine · Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata

  • Gabriella Giarratano, Medicine · Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-08-29
Completion
2022-09-30

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 NCT05984641 on ClinicalTrials.gov