First and second degree hemorrhoids MedDRA version: 9.1 Level: LLT Classification code 10016701 Term: First degree haemorrhoids MedDRA version: 9.1 Level: LLT Classification code 10039799 Term: Second degree haemorrhoids MedDRA version: 9.1 Level: LLT Classification code 10060718 Term: Hemorrhoidal sclerotherapy
Conditions
Interventions
Trade Name: Aethoxysklerol 4%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LAUROMACROGOL 400
CAS Number: 9015558
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Chemische Fabrik Kreussler & Co. GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients with bleeding first and second degree hemorrhoids 2. Age 20-78 years 3. Weight > 50 kg 4. Patients who give written consent after oral and written information about the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Exclusion of pregnancy for female patients not possible 2. Breastfeeding 3. Patients with third or fourth degree hemorrhoids 4. Known allergy to Polidocanol (macrogol lauryl ether, Lauromacrogol 400) or other ingredients of Aethoxysklerol 5. Known allergy to Phenol, almond oil, almonds or nuts 6. Alcoholism 7. Patients who had a sclerotherapy due to hemorrhoidal disease within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Absence of bleeding 4 weeks after last sclerotherapy;Secondary Objective: 1. Safety of Aethoxysklerol evaluated by occurence of adverse drug reactions in comparison to Oily Phenol Injection BP 2. Absence of itching 4 weeks after last sclerotherapy 3. Absence of burning 4 weeks after last sclerotherapy 4. Number of necessary sclerotherapies 5. Patient satisfaction 6. Quality of life (questionnaire) 7. Pain during and directly after sclerotherapy 8. Number of patients with re-interventions;Primary end point(s): Absence of bleeding during or directly after defecation 4 weeks after the last sclerotherapy | — |
Countries
Germany
Outcome results
None listed