Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

PHASE3TerminatedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

May 31, 2010

Study Completion Date

August 31, 2010

Conditions
Chronic PainOsteoarthritis
Interventions
DRUG

Tapentadol PR

"Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 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 4, Melbourne

Site 2, Perth

Site 4, Aalborg

Site 7, Hvidovre

Site 6, Kolding

Site 2, Odense

Site 3, Vejle

Site 1, Berlin

Site 7, Katzhütte

Site 2, Leer

Site 8, Leipzig

Site 9, Zerbst

Site 4, Lublin

Site 5, Ostrów Mazowiecka

Site 2, Tychy

Site 4, Madrid

Site 1, Valencia

Site 3, Birmingham

Site 6, Carmarthen

Site 1, Leeds

Site 2, London

Site 8, Middlesbrough

Site 9, Oxford

Site 10, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY