Placebo-controlled double-blind trial investigating the efficacy and tolerability of Posterisan® akut with lidocaine (50 mg/g rectal ointment) in abatement of complaints associated with the anorectal symptom complex

• Conditions: Relief of complaints associated with anorectal symptom complex (pain, burning, itching); MedDRA version: 14.1Level: HLTClassification code 10002580Term: Anorectal therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-006283-42-DE
• Lead Sponsor: Dr. Kade Pharmazeutische Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

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