Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

PHASE4CompletedINTERVENTIONAL
Enrollment

622

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Low Back PainNeuropathic Pain
Interventions
DRUG

Tapentadol Prolonged Release

100 - 500 mg per day orally twice daily for a maximum of 12 weeks

DRUG

Tapentadol Prolonged Release with Pregabalin

Tapentadol Prolonged Release 100 - 300 mg per day with Pregabalin 150 - 300 mg per day orally twice daily for a maximum of 12 weeks

DRUG

Tapentadol Prolonged Release open label maintenance

100 - 400 mg per day Tapentadol Prolonged Release orally administered twice daily

Trial Locations (59)

10787

DE 118, Berlin

Unknown

Site 506, Klagenfurt

Site 503, Senftenberg

Site 501, Vienna

Site 502, Vienna

Site 504, Vienna

Site 505, Vienna

Site 605, Dour

Site 602, Genk

Site 603, Gozée

Site 604, Ham

Site 601, Pellenberg

Site 702, Copenhagen

Site 704, Frederiksberg

Site 701, Glostrup Municipality

Site 703, Ringsted

Site 107, Berlin

Site 111, Böhlen

Site 105, Cologne

Site 116, Cologne

Site 115, Cottbus

Site 103, Hamburg

Site 110, Hamburg

Site 101, Kiel

Site 114, Kiel

Site 113, Leipzig

Site 109, Lübeck

Site 106, Rendsburg

Site 108, Schönau

Site 117, Weimar

Site 112, Westerstede

Site 104, Wiesbaden

Site 803, Amsterdam

Site 804, Eindhoven

Site 805, Enschede

Site 802, Heerenveen

Site 801, Sliedrecht

Site 309, Bydgoszcz

Site 312, Gdansk

Site 303, Katowice

Site 308, Krakow

Site 310, Krakow

Site 311, Krakow

Site 307, Lublin

Site 306, Ostrów Mazowiecka

Site 304, Poznan

Site 301, Warsaw

Site 302, Warsaw

Site 305, Wroclaw

Site 904, A Coruña

Site 908, Alicante

Site 901, Badalona

Site 905, Barcelona

Site 902, Centelles

Site 907, Granada

Site 909, Madrid

Site 910, Madrid

Site 903, Oviedo

Site 911, Valencia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Grünenthal GmbH

INDUSTRY