Prospektive randomisierte Phase II/III-Studie zur selektiven COX-2-Inhibition beim chronischen Subduralhämatom(Prospective randomized phase II/III study for the selective COX-2-inhibition in chronic subdural haematoma) - COXIBRAIN I

Phase 1

• Conditions: chronic subdural haematoma; MedDRA version: 9.1Level: LLTClassification code 10049162Term: Chronic subdural haematoma

• Registration Number: EUCTR2008-000247-34-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-05
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

patients with chronic subdural haematomas who underwent the surgical treatment without relevante hemorrhages, age 18 years and older (no maximal age), Karnofsky index of at least 70%, written informed consent, negative pregnancy-test in fertile women with birth-controll-methods (defined pearl < 1), no participation in another AMG-study within one month prior to the participation in COXIBRAIN-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

patients with acute subdural haematoma, trauma with contusio cerebri, trauma with compressio cerebri, local chemotherapy, local radiotherapy, allergy to sulfonamide or celecoxib, active gastric ulcera or bleeding, allergic reaction to ASS or NSAR including COX-2-inhibitors, severe liver disorder (albumine < 25g/dl, Child-Pugh >10), severe kidney disorder (creatinine clearance <30ml/h), inflammatory gastric/colon diseases, severe heart insufficiency (NYHA II-IV classification), coronary heart syndrom, cerebrovascular disorder, peripheral artery disease, active vaccinations six weeks prior to participation in COXIBRAIN-study, active Hep B/C infection, pregnancy, neurologic/psychiatric diseases, existing celecoxib medication

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective in this trial is to reduce the relapse rate of chronic subdural haematoma in patients by administering selective COX-2-inhibitors.;Secondary Objective: Secondary objectives are the reduction of secondary surgery due to haemorrhages and the reduction of the length of the hospital stay.;Primary end point(s): primay endpoint is the relapse rate of chronic subdural haematoma