Clinical trial to evaluate and compare the efficacy and safety of Hemorrane® Plus

Phase 1

• Conditions: Bleeding grade I hemorrhoids; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-003024-20-ES
• Lead Sponsor: FAES FARMA SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

1. Age: over 18 years.
2. Sex: both sexes.
3. Patients with grade I and II hemorrhoids.
4. Patients with pain assessed according to Visual Analogue Scale = 5 points.
5. Patients with pruritus and burning-sting evaluated according to Visual Analogue Scale = 5 points.
6. The patient must commit to comply with the hygienic-dietary measures established for the general management of hemorrhoids.
7. Urinary test of negative pregnancy in women.
8. Patients with adequate level for understanding the study.
9. The patient must have voluntarily signed the Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have used other topical antihemorrhoids or other topical agents applicable in the same anorectal area for at least one week before the start of the study (Visit 1, day 1), nor their use throughout the study
2. Hemorrhoidal surgical intervention that is scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15).
3. Severe liver disease (Child-Pugh C).
4. Severe or terminal renal failure documented in the patient's medical history.
5. Moderate to severe cardiovascular disease documented in the patient's medical history.
6. History of hypersensitivity to any of the active ingredients or components of the products under investigation.
7. Active hemorrhoidal hemorrhage or for any other cause.
8. Patients with other pathologies with symptoms similar to hemorrhoidal disease, and patients with more serious pathologies that may cause rectorrhagia.
9. Patients with bacterial, viral and / or fungal infections of the perianal region. 10. Have the diagnostic test for pancreatic puncture with bentiromide scheduled from Visit 1 (day 1) to the follow-up visit Visit 3 (day 15).
11. Be on treatment with any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, local ester anesthetics) for at least one week before the start of the study (Visit 1, day 1), or its use throughout the study.
12. Any other medical and / or therapeutic circumstance considered by the researcher that prevents adequate follow-up and / or adequate evolution of the response to the study treatments.
13. Pregnant women or positive pregnancy test, and lactating women.
14. Women of childbearing age who do not undertake to take the pregnancy test and use valid contraceptive methods during the study and up to one week after the end of the study. The following are considered valid contraceptive methods: barrier method (diaphragm, condom), intrauterine device (IUD), vasectomized couple, sexual abstinence, hormonal contraceptives, intrauterine system (SIU), bilateral tubal occlusion.
15. HIV positive patients known in the last five years.
16. Patients with active cancer process in the last five years.
17. Patients who have received an investigational drug (including vaccines) or have used an invasive medical device under investigation in the last 30 days prior to the start of the selection phase or are currently participating in another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified