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

NCT ID: NCT01904149

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-05-31

Brief Summary

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only).

Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Detailed Description

In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

• DKP/TRAM followed by DKP/TRAM;
• DKP followed by DKP;
• TRAM followed by TRAM;
• placebo followed by DKP;
• placebo followed by TRAM;
• placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DKP/TRAM followed by DKP/TRAM

Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses

Group Type: EXPERIMENTAL

Dexketoprofen/Tramadol-single dose

Intervention Type: DRUG

Dexketoprofen/Tramadol single oral dose (first 8 hours)

Dexketoprofen/Tramadol-multiple doses

Intervention Type: DRUG

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

DKP followed by DKP

Dexketoprofen-single dose followed by Dexketoprofen-multiple doses

Group Type: ACTIVE_COMPARATOR

Dexketoprofen-single dose

Intervention Type: DRUG

Dexketoprofen single oral dose (first 8 hours)

Dexketoprofen-multiple doses

Intervention Type: DRUG

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

TRAM followed by TRAM

Tramadol-single dose followed by Tramadol-multiple doses

Group Type: ACTIVE_COMPARATOR

Tramadol-single dose

Intervention Type: DRUG

Tramadol single oral dose (first 8 hours)

Tramadol-multiple doses

Intervention Type: DRUG

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

Placebo followed by DKP/TRAM

Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo single oral dose (first 8 hours)

Dexketoprofen/Tramadol-multiple doses

Intervention Type: DRUG

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

Placebo followed by DKP

Placebo single dose followed by Dexketoprofen-multiple doses

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo single oral dose (first 8 hours)

Dexketoprofen-multiple doses

Intervention Type: DRUG

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

Placebo followed by TRAM

Placebo single dose followed by Tramadol-multiple doses

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo single oral dose (first 8 hours)

Tramadol-multiple doses

Intervention Type: DRUG

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

Interventions

Placebo

Placebo single oral dose (first 8 hours)

Intervention Type: DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

Intervention Type: DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

Intervention Type: DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol single oral dose (first 8 hours)

Intervention Type: DRUG

Dexketoprofen-multiple doses

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

Intervention Type: DRUG

Tramadol-multiple doses

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

Intervention Type: DRUG

Dexketoprofen/Tramadol-multiple doses

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients aged 18 to 75 years.
• Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions.
• Patients experiencing pain at rest of at least moderate intensity the day after surgery.

Exclusion Criteria

• Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.
• Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.
• Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.
• Patients using and not suitable to withdraw analgesics other than those specified in the protocol.
• Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.
• Breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry J McQuay, Professor

Role: STUDY_CHAIR

Balliol College Oxford

Andrew Moore, Professor

Role: STUDY_CHAIR

Pain Research & Nuffield Department of Anaesthetics - University of Oxford

Locations

Bajcsy-Zsilinszky Kórház

Budapest, , Hungary

University Hospital of Debrecen

Debrecen, , Hungary

Dr. Bugyi István Kórház

Szentes, , Hungary

Fejér megyei Szent György Kórház

Székesfehérvár, , Hungary

Juras Medicinas Centre

Riga, , Latvia

Riga East University Hospital Gynecology Clinic

Riga, , Latvia

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, , Lithuania

Vilniaus gimdymo namai

Vilnius, , Lithuania

Samodzielny Publiczny Szpital Kliniczny nr 1

Lublin, Lublin Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, Lublin Voivodeship, Poland

Prywatna Klinika Polozniczo-Ginekologiczna

Bialystok, , Poland

Ginekologiczno-Polożniczy Szpital Kliniczny UM w Poznaniu

Poznan, , Poland

Wojewodzki Szpital

Przemyśl, , Poland

Specjalistyczny Szpital im. E. Szczeklika

Tarnów, , Poland

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini

Warsaw, , Poland

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, , Poland

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

Bucharest, , Romania

Genesys Fertility Center

Bucharest, , Romania

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

Bucharest, , Romania

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

Bucharest, , Romania

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Spitalul Clinic de Urgenta "Sfantul Pantelimon"

Bucharest, , Romania

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

Târgu Mureş, , Romania

Moscow Regional Research Institute of Obstetrics and Gynecol

Moscow, , Russia

FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA

Saint Petersburg, , Russia

GYNPOR, s.r.o.

Sliač, , Slovakia

Hospital Universitario Arnau de Vilanova

Lleida, Lérida, Spain

Complejo Hospitalario Arquitecto Marcide

Ferrol, , Spain

Countries

Hungary; Latvia; Lithuania; Poland; Romania; Russia; Slovakia; Spain

References

Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.

Reference Type: RESULT

PMID: 26801905 (View on PubMed)

Other Identifiers

2012-004545-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEX-TRA-04

Identifier Type: -

Identifier Source: org_study_id