A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

PHASE3CompletedINTERVENTIONAL
Enrollment

990

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
PainKnee Osteoarthritis
Interventions
DRUG

Tapentadol ER (100 to 250 mg twice daily)

50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)

DRUG

Matching Placebo (twice daily)

Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)

DRUG

Oxycodone CR (20 to 50 mg twice daily)

10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)

Trial Locations (100)

Unknown

Site 043005, Innsbruck

Site 043006, Mitterdorf

Site 043002, Salzburg

Site 043001, Vienna

Site 043004, Vienna

Site 043003, Wiener Neustadt

Site 385003, Karlovac

Site 385001, Osijek

Site 385004, Sisak

Seite 385005, Zagreb

Site 385002, Zagreb

Site 049002, Berlin

Site 049008, Berlin

Site 049010, Berlin

Site 049003, Dresden

Site 049004, Frankfurt

Site 049007, Hamburg

Site 049001, Leipzig

Site 049005, Magdeburg

Site 049009, Schwerin

Site 049006, Wiesbaden

Site 036003, Budapest

Site 036005, Budapest

Site 036006, Budapest

Site 036009, Budapest

Site 036008, Debrecen

Site 036004, Kecskemét

Site 036007, Kecskemét

Site 036002, Visegrád

Site 039002, Chieti

Site 039003, Milan

Site 039004, Pavia

Site 039001, Perugia

Site 371002, Bauska

Site 371004, Riga

Site 371005, Riga

Site 031008, Eindhoven

Site 031003, Losser

Site 031006, Oude Pekela

Site 031004, s'Hertogenbosch

Site 031007, Spijkenisse

Site 048007, Bielsko-Biala

Site 048005, Gmina Końskie

Site 048006, Katowice

Site 048004, Krakow

Site 048001, Lublin

Site 048008, Mielec

Site 048003, Piekary Śląskie

Site 048010, Rzeszów

Site 048009, Warsaw

Site 048002, Wroclaw

Site 048011, Wroclaw

Site 351001, Coimbra

Site 351003, Faro

Sites 351008, Funchal

Site 351005, Guimarães

Site 351004, Lisbon

Site 351009, Lisbon

Site 351002, Ponta Delgada

Site 040001, Bucharest

Site 040002, Bucharest

Site 040005, Bucharest

Site 040006, Bucharest

Site 040007, Bucharest

Site 040008, Bucharest

Site 040009, Bucharest

Site 040011, Bucharest

Site 040004, Campulung Muscel

Site 040010, Craiova

Site 421005, Banská Bystrica

Site 421001, Košice

Site 421003, Poprad

Site 421004, Prešov

Site 421002, Rimavská Sobota

Site 034002, Alicante

Site 034009, Benidorm

Site 034005, L'Hospitalet de Llobregat

Site 034007, La Roca del Vallès

Site 034015, Málaga

Site 034008, Móstoles

Site 034003, Oviedo

Site 034013, Oviedo

Site 034016, Seville

Site 034001, Torrelavega

Site 034012, Valencia

Site 034004, Vic

Site 044012, Birmingham

Site 044004, Blackpool

Site 044009, Bradford

Site 044013, Cardiff

Site 044002, Chesterfield

Site 044018, Chorley

Site 044005, Ecclesfield

Site 044008, Falkirk

Site 044001, Kenton

Site 044006, London

Site 044011, London

Site 044016, Reading

Site 044003, Solihull

Site 044007, Woolpit

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY