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

PHASE3CompletedINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Acute Pain
Interventions
DRUG

Placebo

Placebo single oral dose (first 8 hours)

DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen-multiple doses

Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)

DRUG

Tramadol-multiple doses

Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

DRUG

Dexketoprofen/Tramadol-multiple doses

Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Trial Locations (28)

1106

Bajcsy-Zsilinszky Kórház, Budapest

8000

Fejér megyei Szent György Kórház, Székesfehérvár

15405

Complejo Hospitalario Arquitecto Marcide, Ferrol

21623

"Spitalul Clinic de Urgenta Sfantul Pantelimon", Bucharest

25198

Hospital Universitario Arnau de Vilanova, Lleida

101000

Moscow Regional Research Institute of Obstetrics and Gynecol, Moscow

194291

FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA, Saint Petersburg

540136

Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I, Târgu Mureş

H-4012

University Hospital of Debrecen, Debrecen

H-6600

Dr. Bugyi István Kórház, Szentes

LV-1005

Juras Medicinas Centre, Riga

LV-1038

Riga East University Hospital Gynecology Clinic, Riga

LT-50009

Hospital of Lithuanian University of Health Sciences Kaunas, Kaunas

LT-02106

Vilniaus gimdymo namai, Vilnius

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1, Lublin

20-954

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin

15-224

Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok

60-535

Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu, Poznan

37-700

Wojewodzki Szpital, Przemyśl

33-100

Specjalistyczny Szpital im. E. Szczeklika, Tarnów

00-909

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini, Warsaw

02-507

Centralny Szpital Kliniczny MSW w Warszawie, Warsaw

011062

"Institutul pentru Ocrotirea Mamei si Copilului (IOMC) Prof. Dr. Alfred Rusescu", Bucharest

011475

Genesys Fertility Center, Bucharest

020475

"Spitalul Clinic Dr. Ioan Cantacuzino - Sectia Clinica Obstetrica Ginecologie II", Bucharest

"Spitalul Clinic Dr. Ioan Cantacuzino - Sectia Clinica Obstetrica Ginecologie I", Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

962-31

GYNPOR, s.r.o., Sliač

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT01904149 - Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride | Biotech Hunter | Biotech Hunter