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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000247-34-DE
Enrollment
180
Registered
2008-08-05
Start date
2008-09-26
Completion date
Unknown
Last updated
2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic subdural haematoma MedDRA version: 9.1 Level: LLT Classification code 10049162 Term: Chronic subdural haematoma

Interventions

Trade Name: Celebrex Product Name: Celebrex Product Code: Celebrex Pharmaceutical Form: Capsule, hard INN or Proposed INN: Celecoxib CAS Number: 169590-42-5 Concentration unit: mg milligram(s) Concent

Sponsors

Charité – Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026