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

NCT05984641 | Completed

• 1 other identifier: CONAN2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Haemorrhoids; anal fissures; controlled clinical trial.

Outcome Measures

Primary Outcomes (1)

• Change in the symptom numerical rating scale

  The primary outcome was the change in the symptom numerical rating scale (NRS) score after one month (V3) of treatment compared to the baseline in the two groups.

  30 days

Secondary Outcomes (1)

• Evaluation of potential adverse events and treatment compliance

  30 days

Study Arms (2)

Group A

EXPERIMENTAL

Active treatment CONAN® (Medical Device, Omikron Italia Srl) a proctological cream containing 2.5% glycerin macerate from horse chestnut buds (escin), 1% hesperidin, 0.1% hyaluronic acid, 0.1% centella asiatica and 2.5% glycerinic extract of mallow; Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

Device: CONAN® Proctological Cream

Group B

NO INTERVENTION

No intervention. Instrutction to an healthy diet including an adequate fibre intake and general advice for facilitating evacuation using stool softeners.

Interventions

CONAN® Proctological Cream DEVICE

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.

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years
• Hemorrhoidal pathology, anal fissures and anitis
• NRS score ≥ 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body)

You may not qualify if:

• Known hypersensitivity to study products
• Proctitis
• Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
• Pregnancy, breastfeeding

Sponsors & Collaborators

• Omikron Italia S.r.l.: lead

Study Sites (1)

Policlinico Tor Vergata Foundation (PTV)

Rome, 00133, Italy

Location

MeSH Terms

Conditions

Hemorrhoids; Fissure in Ano

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicola Di Lorenzo, Medicine

  Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

• Gabriella Giarratano, Medicine

  Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: March 1, 2022
• Primary Completion: August 29, 2022
• Study Completion: September 30, 2022
• Last Updated: April 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)