Hemorrhoids Grade I and IINCT05124379
Hemoclin Gel for the Treatment of Hemorrhoids
A study testing Hemoclin Gel in people with Hemorrhoids Grade I and II, run by Karo Pharma AB at 1 site in Poland.
Trial summary
Post market, single arm, clinical investigation to assess safety and performance of the product. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids Grade I and II
- What is being tested?
- Hemoclin Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2021to 19 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects.
- Sex: male or female.
- Age: more than 18 years old.
- Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
- Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
- Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily, whether or not you feel the need to have a bowel movement that day).
- Able and willing to provide informed consent and comply with study procedures
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject not able or not willing to provide informed consent and comply with study procedures
- Subject who had been deprived of their freedom by administrative or legal decision.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject in a social or sanitary establishment.
- Subject suspected to be non-compliant according to the Investigator's judgment. In terms of associated pathology
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- Grade III or IV haemorrhoids (Goligher classification).
- Other pre-existing anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections.
- Any anal surgery (including surgical or instrumental procedures in the last 60 days). Relating to previous or ongoing treatment
- Any anal topical medication applied in last 7 days.
- Known or suspected sensitivity or allergy to ingredients of the investigational product. In terms of COVID pandemic
- Subject who was abroad in a country with higher incidence rate of Covid-19 than Poland within 14 days before the beginning of the study.
- Subject presenting following symptoms: cough, shortness of breath, elevated body temperature - equal and above 37.5°C.
- Subject who had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
- Subject who is currently during home quarantine recommended by the Sanitary Inspection
Trial locations and contacts
1 site in 1 country.
Poland1 site
GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"
Gdansk
About this study
Official title: Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.
Post market, single arm, clinical investigation to assess safety and performance of the product.
- Conditions
- Hemorrhoids Grade I and II
- Being tested
- Hemoclin Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoclin GelDevice
Non sterile gel for intra-rectal use
| Study group | Role | What they receive |
|---|---|---|
| Hemoclin Gel | Other | Not described Receives: Device: Hemoclin Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
Severity of itch will be evaluated by the patient with a 6 point structured scale.
Measured: 2 weeks
Secondary outcomes (4)
To evaluate by the patient the efficacy of tested product on the severity of bleeding
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Measured: 2 weeks
To evaluate by the patient the efficacy of tested product on the sense of discomfort
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Measured: 2 weeks
To evaluate the overall satisfaction of the patient according to
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Measured: 2 weeks
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Nov 2021
- Primary completion17 Nov 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhoids Grade I and IIStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124379
- Sponsor's protocol ID
- 21E1799/HC_001
- Status last verified
- Mar 2022
- First submitted
- 26 Oct 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.
- ClinicalTrials.gov ID
- NCT05124379
- Acronym / sponsor ID
- 21E1799/HC_001
- Conditions
- Hemorrhoids Grade I and II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 18 Nov 2021 (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.
Post market, single arm, clinical investigation to assess safety and performance of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoclin Gel | Other | Device: Hemoclin Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects.
- Sex: male or female.
- Age: more than 18 years old.
- Symptomatic haemorrhoids stage 1 and 2 (Goligher classification).
- Episodes of haemorrhoid-related itching experienced at least every other day during the last two weeks before enrolment in the study.
Key exclusion criteria (15 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject not able or not willing to provide informed consent and comply with study procedures
- Subject who had been deprived of their freedom by administrative or legal decision.
- Major subject who is under guardianship or who is not able to express his consent.
- Subject in a social or sanitary establishment.
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 |
|---|---|---|
| Hemoclin GelNon sterile gel for intra-rectal use | Device | Hemoclin Gel |
Primary outcome
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
Time frame: 2 weeks
Severity of itch will be evaluated by the patient with a 6 point structured scale.
4 secondary outcomes
To evaluate by the patient the efficacy of tested product on the severity of bleeding
Time frame: 2 weeks
To evaluate by the patient the efficacy of tested product on the sense of discomfort
Time frame: 2 weeks
To evaluate the overall satisfaction of the patient according to
Time frame: 2 weeks
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,
Time frame: 2 weeks
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 31 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoclin Gel in people with Hemorrhoids Grade I and II, run by Karo Pharma AB at 1 site in Poland.
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 7 inclusion and 15 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 31 Mar 2022. 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 Poland. 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?
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II. (time frame: 2 weeks). 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 31 Mar 2022.