Back to resultsHemoclin Gel for the Treatment of Hemorrhoids
Primary Purpose
Hemorrhoids Grade I and II
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Hemoclin Gel
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids Grade I and II
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hemoclin Gel
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05124379
Brief Title
Hemoclin Gel for the Treatment of Hemorrhoids
Official Title
Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
January 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Pharma AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Post market, single arm, clinical investigation to assess safety and performance of the product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids Grade I and II
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemoclin Gel
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Hemoclin Gel
Intervention Description
Non sterile gel for intra-rectal use
Primary Outcome Measure Information:
Title
The primary objective is to asses the treatment of itch related to Haemorrhoids grade I or II.
Description
Severity of itch will be evaluated by the patient with a 6 point structured scale.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
To evaluate by the patient the efficacy of tested product on the severity of bleeding
Description
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time Frame
2 weeks
Title
To evaluate by the patient the efficacy of tested product on the sense of discomfort
Description
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time Frame
2 weeks
Title
To evaluate the overall satisfaction of the patient according to
Description
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time Frame
2 weeks
Title
To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,
Description
Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"
City
Gdańsk
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemoclin Gel for the Treatment of Hemorrhoids
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