Clinical and application studies of Avextra

Summary Scope:

• Early Palliative care in oncology patients
• Phase 2 RTC double blinded

Centers:

Main center: Kiel University

Subjects:

170 patients

Approval through BfArM and the Ethics Committee Schleswig-Holstein, Kiel

Summary Scope:

• CINP: Chemotherapy induced Neuropathic Pain
• Prospective, non-interventional, 12-week parallel group study

Partners:

Deutsche Gesellschaft für Schmerzmedizin e.V

Subjects:

400 patients

Berufsrechtlichen Beratung durch die Ethik-Kommission der Landesärztekammer Baden-Württemberg

Summary Scope:

• Different galenic forms
• Non-interventional, open, prospective

Partners:

Medical University Mannheim,
represented by Prof. Dr. med. Justus Benrath

Subjects:

500 patients

Ethics Committee, Mannheim

Summary Scope:

Improvement of psycho-psychological symptoms of chronic pain patients with prominent or pronounced insomnia

Subjects:

100 patients

Study director:

Dr. med. Richard Ibrahim, München

Ethics Committee, Bavaria

Summary Scope:

• Reduction of overall symptom burden in patients with complex palliative situations
• Monocentric, prospective, non-interventional, open, parallel observational study

Sponsor:

Prof. Dr. med. Sven Gottschling

Subjects:

150 patients

Study director:

Prof. Dr. med. Sven Gottschling

Ethik-Kommission Saarbrücken