A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

854

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

April 30, 2008

Conditions
HysterectomyPostoperative
Interventions
DRUG

Morphine

20 mg IR; 4 - 6 hourly; Total 72 hours

DRUG

CG5503 IR

50mg; 4 - 6 hourly; Total 72 hours

DRUG

CG5503 IR

75mg; 4 -6 hourly; Total 72 hours

DRUG

CG5503 IR

100mg, 4 - 6 hourly; Total 72 hours

DRUG

Placebo

4 - 6 hourly; Total 72 hours

Trial Locations (52)

Unknown

Site 13, Békéscsaba

Site 14, Debrecen

Site 15, Komárom

Site 12, Nyíregyháza

Site 16, Riga

Site 17, Riga

Site 18, Riga

Site 19, Riga

Site 27, Katowice

Site 23, Krakow

Site 24, Lodz

Site 66, Lodz

Site 22, Lublin

Site 25, Lublin

Site 26, Ruda Śląska

Site 20, Warsaw

Site 21, Warsaw

Site 28, Wroclaw

Site 33, Brasov

Site 78, Brasov

Site 29, Bucharest

Site 30, Bucharest

Site 31, Bucharest

Site 32, Bucharest

Site 34, Bucharest

Site 35, Bucharest

Site 36, Bucharest

Site 76, Bucharest

Site 75, Craiova

Site 61, Ploieşti

Site 71, Belgorod

Site 37, Moscow

Site 38, Moscow

Site 44, Moscow

Site 73, Moscow

Site 42, Saint Petersburg

Site 43, Saint Petersburg

Site 45, Belgrade

Site 47, Belgrade

Site 46, Kragujevac

Site 70, Novi Sad

Site 48, Banská Bystrica

Site 51, Bratislava

Site 52, Bratislava

Site 62, Košice

Site 50, Martin

Site 53, Maribor

Site 64, Donetsk

Site 55, Kiev

Site 56, Kiev

Site 58, Kiev

Site 67, Zaporizhya

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

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

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY