Relief of complaints associated with hemorrhoids (pain, burning, itching) MedDRA version: 14.1 Level: HLT Classification code 10002580 Term: Anorectal therapeutic procedures System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Posterisan® akut mit Lidocain 60 mg/ Zäpfchen
Product Name: Posterisan® akut mit Lidocain 60 mg/Zäpfchen
Pharmaceutical Form: Suppository
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-
Sponsors
Dr. Kade Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - signed informed consent - adults = 18 years - patients with complaints associated with hemorrhoids (pain or burning or itching) - at least one of the symptoms associated with hemorrhoids (pain, burning, itching) hast to be = 65 on the visual analogue scale (VAS): Most bothersome symptom 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Intra-anal or peri-anal thrombosis - hemorroides grade III and IV - known type IV hypersensitivity - diagnosed rectal carcinoma - diagnosed chronic inflammatory bowel diseases (Morbus Crohn, Colitis ulcerosa) - anorectal infection - use of symptoms' relieving medications (e.g. antihistamines, local anesthetics, analgetics), or in the context of any causal treatment, which could influence the symptoms pain, burning or itching, one week before screening - hypersensitivity against lidocaine or any other substance of the investigational product - known or suggested drug or alcohol abuse - pregnancy and lactation - participation on a clinical trial 12 weeks before screening - committal to an institution due to an official or court order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of superior efficacy of Posterisan® akut mit Lidocain 60 mg/Zäpfchen compared with placebo (vehicle without active substance) in the relief of symptoms associated with hemorrhoids;Secondary Objective: Determining the local tolerability/safety of Posterisan® akut mit Lidocain 60 mg/Zäpfchen in the relief of symptoms associated with hemorrhoids;Primary end point(s): Improvement (decrease) in the subjective most bothersome symptom (MBS) of hemorrhoids: Difference VAS T0 - VAS T3 ;Timepoint(s) of evaluation of this end point: Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Comparison in the change between verum and placebo in the most bothersome symptom (MBS) an days 1 and 2 (Difference VAS T0 - VAS T1 or T2) - Change in the MBS on days 1, 2 and 3 in comparison to screening (T0) - Subgroup analysis: Improvement in the particular symptom (pain, burning, itching): Difference VAS T0 - VAS T3 - Responders/Non-responders (responders: MBS on VAS = 30 mm) - Evaluation of tolerability by the physician - Evaluation of tolerability by the patient;Timepoint(s) of evaluation of this end point: Day 1 - 3 (depending on the sec. endpoint) | — |
Countries
Germany
Contacts
Public ContactClinical Research
Dr. Kade Pharmazeutische Fabrik GmbH
Outcome results
None listed