Detail of the clinical trial
| Title of the trial | An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic nociceptive, mixed or neuropathic low back pain taking WHO step III analgesics but showing a lack of tolerability |
|---|---|
| EudraCT number | 2009-010428-25 |
| Protocol number | KF5503/45 |
| Sponsor | Grunenthal GmbH, Germany |
| Indications | Pain disorders |
| Diagnosis | severe chronic nociceptive, mixed or neuropathic low back pain |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2009 |
| Date of approval by Institute (SÚKL) | 15.2.2010 |
| Date of approval by EC | 18.1.2010 |
| Date of initiation CT in ČR | 22.3.2010 |
| Date of ending CT in ČR | 11.3.2011 |
| Notice | |
| Sites |
Centrum bolesti, FN U sv. Anny, Brno Centrum bolesti, FN Olomouc Centrum bolesti, FN Ostrava |
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