Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

PHASE3CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

June 30, 2010

Study Completion Date

September 30, 2010

Conditions
Chronic PainOsteoarthritis
Interventions
DRUG

Tapentadol

"Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day.~Maintenance Period: Participants continuing on the dose established in the previous period."

Trial Locations (24)

Unknown

Site 1, Belfort

Site 4, Marseille

Site 2, Murs Erigné

Site 3, Nantes

Site 5, Berlin

Site 2, Köln Dünnwald

Site 4, Leipzig

Site 6, Leipzig

Site 1, Marl

Site 3, Meine

Site 8, Rudolstadt

Site 4, Lodz

Site 2, Warsaw

Site 2, A Coruña

Site 7, A Coruña

Site 6, Lugo

Site 3, Madrid

Site 1, Torrelavega

Site 3, London

Site 9, London

Site 06, Manchester

Site 08, Portsmouth

Site 1, Solihull

Site 4, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY