Placebo-controlled double-blind study about the effectiveness of longtime acetylsalicylic acid desactivation therapy as prevention of recurrens of poyposis nasi in case of acetylsalicylic acid intolerance
- Conditions
- chronic rhinosinusistis, polyposis nasi, aspirin intolerance
- Registration Number
- EUCTR2005-004437-18-DE
- Lead Sponsor
- Department of Otolaryngology, Head and Neck Surgery Johannes Gutenberg-Universität Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
age mor than 18, polyposis nasi, clinical signs of ASS-intolerance and pathological variations of the eicosanoid metabolism in vitro, actual state after endonasal sinus surgery in case of chronic rhinosinusitis.
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
systemical treatment with steroids within the last 3 weeks befor beginning of the study,
pregnency,
Active peptic ulcer
Haemostatic disorders, including anticoagulant and thrombolytic treatment
Hypoproteinemia
hepatic or renal insufficiency
immune deficiency
glucose-6-phosphatase deficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evidence of the effectiveness of a long-time ASS-desactivation therapy as a prevention of recurrence of polyposis nasi after sinus surgery in cases of recurrent chronic sinusitis with ASS-intolerance;Secondary Objective: Get mor information about the pathological eicosanoid metabolism and the incluence of longtime ASS-therapy;Primary end point(s): ate of recurrence of poyposis nasi/chronic rhinosinusitis after 3 years of ASS-desactivation therapy, tested in radomised, double-blind and pacebo-controled way
- Secondary Outcome Measures
Name Time Method