Skip to main content
OpenTrials
Completed

NCT Number: NCT05124379

Hemoclin Gel for the Treatment of Hemorrhoids

Post market, single arm, clinical investigation to assess safety and performance of the product.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"

Gdansk, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemoclin Gel

Device

Non sterile gel for intra-rectal use

Primary outcomes

  1. 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.

Secondary outcomes

  1. To evaluate by the patient the efficacy of tested product on the severity of bleeding

    Time frame: 2 weeks

    Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.

  2. To evaluate by the patient the efficacy of tested product on the sense of discomfort

    Time frame: 2 weeks

    Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.

  3. To evaluate the overall satisfaction of the patient according to

    Time frame: 2 weeks

    Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.

  4. To evaluate the instant cooling effect, less painful toilet visit each day using a daily log,

    Time frame: 2 weeks

    Wilcoxon signed rank test will be carried out to assess whether the median change from baseline is statistically significant.

Sponsors and collaborators

Lead sponsor

Karo Pharma AB

Industry

Registry information

Official study title

Prospective, Open Clinical Investigation to Confirm the Effectiveness and Safety of Hemoclin Gel for the Treatment of Haemorrhoids.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.