Hemorrhoid PainNCT05984641
Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease
A study testing CONAN® Proctological Cream in people with Hemorrhoid Pain and Haemorrhoid Inflammation, run by Omikron Italia S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoid Pain, Haemorrhoid Inflammation
- What is being tested?
- CONAN® Proctological Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Known hypersensitivity to study products
- Proctitis
- Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
- Surgical treatments undergone less than a year after inclusion
- Pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial
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.
Read the detailed description
Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.
Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.
- Conditions
- Hemorrhoid Pain, Haemorrhoid Inflammation
- Being tested
- CONAN® Proctological Cream
- Keywords
- Haemorrhoids; anal fissures; controlled clinical trial.
- Medical subject headings
- Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONAN® Proctological CreamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
Evaluation of potential adverse events and treatment compliance
The safety of the treatment was investigated by recording and systemic and local adverse events such as systemic allergic reactions, skin sensitisation and discomfort, etc. Treatment compliance was evaluated through assessment by the investigator of the empty study treatment cream tubes returned by patients at the end of the study.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Mar 2022
- Primary completion29 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoid PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omikron Italia S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Di Lorenzo, Medicine, Principal investigator, Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor VergataGabriella Giarratano, Medicine, Study chair, Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984641
- Sponsor's protocol ID
- CONAN2019
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05984641
- Acronym / sponsor ID
- CONAN2019
- Conditions
- Hemorrhoid Pain, Haemorrhoid Inflammation
- Keywords
- Haemorrhoids; anal fissures; controlled clinical trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Omikron Italia S.r.l.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.
Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: CONAN® Proctological CreamActive 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- Known hypersensitivity to study products
- Proctitis
- Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
- Surgical treatments undergone less than a year after inclusion
- Pregnancy, breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONAN® Proctological CreamThe 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. | Device | Group A |
Primary outcome
Change in the symptom numerical rating scale
Time frame: 30 days
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.
1 secondary outcome
Evaluation of potential adverse events and treatment compliance
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Di Lorenzo, Medicine principal investigator
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
Gabriella Giarratano, Medicine study chair
Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONAN® Proctological Cream in people with Hemorrhoid Pain and Haemorrhoid Inflammation, run by Omikron Italia S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the symptom numerical rating scale (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.