Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride

PHASE3CompletedINTERVENTIONAL
Enrollment

641

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Acute Pain
Interventions
DRUG

Placebo

Placebo single oral dose (first 8 hours)

DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol oral single dose (first 8 hours)

DRUG

Tramadol-multiple doses

Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

DRUG

Dexketoprofen-multiple doses

Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)

DRUG

Dexketoprofen/Tramadol-multiple doses

Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

Trial Locations (37)

404

China Medical University Hospital [Orthopedic], Taichung

433

Kuang Tien General Hospital, Taichung

1145

Uzsoki Hospital, Department of Orthopaedics, Budapest

5000

MÁV Kórház és Rendelőintézet, Ortopédiai osztály, Szolnok

7632

PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze, Pécs

8000

Fejér Megyei Szent György Kórház, Székesfehérvár

11000

Clinical Center of Serbia, Belgrade

Institute for orthopedic Surgery Banjica [Ortopedic Surgery, Belgrade

11009

Hospital Universitario Puerta del Mar, Cadiz

18000

Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica, Niš

18009

Cherkaska oblasna likarnia, Cherkasy

34000

Clinical Center Kragujevac, Kragujevac

61024

Instytut patologii khrebta ta suglobiv im. prof. M.I. Sytenka NAMN Ukraine, Kharkiv

65929

Klinikum Frankfurt Höchst GmbH, Frankfurt am Main

92288

Klaipedos Universitetine ligonine, Klaipėda

99018

Sevastopolska miska likarnia №9, Sevastopol

625 00

Fakultni nemocnice Brno, Brno

662 50

Urazova nemocnice v Brne, Brno

586 33

Nemocnice Jihlava, p.o., Jihlava

272 59

Oblastni nemocnice Kladno, Kladno

293 50

Oblastni nemocnice Mlada Boleslav a.s., Mladá Boleslav

H-4012

University of Debrecen, Debrecen

LV-3414

Liepaja Regional Hospital, Liepāja

LV-1004

Riga's 2nd Hospital, Riga

LV-1005

Hospital of Traumatology and Orthopaedics, Riga

LV-4201

Vidzemes Hospital, Valmiera

LT-44320

Kaunas Clinical Hospital, Kaunas

LT-50009

Hospital of Lithuanian University of Health Sciences Kaunas, Kaunas

LT-04130

Respublikine Vilniaus universitetine ligonine, Vilnius

15-276

Uniwersytecki Szpital Klioniczny w Bialymstoku, Bialystok

82-300

Warminskie Centrum Ortopedyczne, Elblag

20-718

Wojewodzki Szpital Specjalistyczny, Lublin

33-100

Specjalistyczny Szpital im. E. Szczeklika, Tarnów

51-128

Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu, Wroclaw

91-002

Medical University of Lodz, Lodz

08024

Hospital L'Esperança. Parc de Salut Mar., Barcelona

04107

Kyivska oblasna klinichna likarnia, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT01902134 - Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride | Biotech Hunter | Biotech Hunter