622
Participants
Start Date
July 31, 2007
Primary Completion Date
June 30, 2012
Study Completion Date
June 30, 2012
Tapentadol Extended Release
Tablet taken orally, twice daily, morning \& evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg.
Matching Placebo after Tapentadol in the Titration Phase.
Tablet taken orally, twice daily, morning \& evening with preferably 12 hours (not less than 6 hours) between doses. In the maintenance phase only to participants that were randomized to tapentadol in the titration phase.
Morphine Sulphate Controlled Release
Capsule taken orally, twice daily, morning \& evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 40 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
Site 034004, Seville
Site 043002, Vienna
Site 043001, Vienna
Site 043005, Vienna
Site 359008, Sofia
Site 373001, Chisinau
Site 373002, Chisinau
Site 036005, Komárom
Site 036003, Mátraháza
Site 359014, Plovdiv
Site 036001, Debrecen
Site 036002, Nyíregyháza
Site 359013, Gabrovo
Site 359011, Pleven
Site 036010, Szekszárd
Site 036006, Székesfehérvár
Site 036009, Székesfehérvár
Site 359012, Varna
Site 043004, Klagenfurt
Site 359004, Shumen
Site 385002, Zagreb
Site 385003, Zagreb
Site 381003, Belgrade
Site 381004, Belgrade
Site 381005, Belgrade
Site 049009, Berlin
Site 049020, Potsdam
Site 046001, Stockholm
Site 381002, Niš
Site 420004, Prague
Site 381001, Kamenitz
Site 420001, Pilsen
Site 385007, Osijek
Site 034012, Pamplona
Site 385001, Slavonski Brod
Site 420002, České Budějovice
Site 385004, Varaždin
Site 049014, Essen
Site 034002, Valencia
Site 420007, Liberec
Site 385006, Zabok
Site 420006, Hradec Králové
Site 049012, Cologne
Site 048007, Poznan
Site 420005, Brno
Site 033101, Tarbes
Site 049002, Wiesbaden
Site 049007, Löwenstein
Site 420008, Olomouc
Site 049006, Waldkirch
Site 039001, Napoli
Site 048005, Gdansk
Site 048004, Bydgoszcz
Site 421005, Banská Bystrica
Site 007003, Moscow
Site 007005, Yaroslavl
Site 007010, Arkhangelsk
Site 040007, Timișoara
Site 007012, Vladikavkaz
Site 040005, Cluj-Napoca
Site 040006, Brasov
Site 007007, Nizhny Novgorod
Site 040001, Iași
Site 048001, Warsaw
Site 040002, Bucharest
Site 040003, Bucharest
Site 040004, Bucharest
Site 421001, Košice
Site 034009, Barcelona
Site 034005, Barcelona
Site 034006, Mahon
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Grünenthal GmbH
INDUSTRY