Hemoclin Gel for the Treatment of Hemorrhoids

NCT05124379 | Completed

• 1 other identifier: 21E1799/HC_001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhoids Grade I and II

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (4)

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

  2 weeks

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

  2 weeks

• To evaluate the overall satisfaction of the patient according to

  2 weeks

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

  2 weeks

Study Arms (1)

Hemoclin Gel

OTHER

Device: Hemoclin Gel

Interventions

Hemoclin Gel DEVICE

Non sterile gel for intra-rectal use

Hemoclin Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karo Pharma AB: lead

Study Sites (1)

GastroDent Gabinet Gastroenterologiczny z Pracownią Endoskopową"

Gdansk, Poland

Location

Study Design

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

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 18, 2021
• Study Start: November 1, 2021
• Primary Completion: November 17, 2021
• Study Completion: January 19, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)