Relief of complaints associated with anorectal symptom complex (pain, burning, itching) MedDRA version: 14.1 Level: HLT Classification code 10002580 Term: Anorectal therapeutic procedures System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe
Product Name: Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe
Pharmaceutical Form: Rectal ointment
INN or Proposed INN: LIDOCAINE
CAS Nu
Sponsors
Dr. Kade Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - signed informed consent - adults = 18 years - patients with the anorectal symptom complex (pain or burning or itching) - at least one of the symptoms from the anorectal symptom complex (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 - rectal carcinoma (suspicion or assured diagnosis) - chronic inflammatory bowel diseases (Morbus Crohn, Colitis ulcerosa) - 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 50 mg/g Rektalsalbe compared with placebo (vehicle without active substance) in the relief of symptoms associated with the anorectal symptom complex;Secondary Objective: Determining the local tolerability/safety of Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe in the relief of symptoms associated with the anorectal symptom complex;Primary end point(s): Improvement (decrease) in the subjective most bothersome symptom (MBS) of the anorectal symptom complex: 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