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

Acute Pain Clinical Trial

— DAVID lap  

Official title:

A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904149
• Other study ID #: DEX-TRA-04
• Secondary ID: 2012-004545-32
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2013
• Last updated: February 4, 2016
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2016
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Research Ethics Medical CommitteeLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Ministry of HealthRomania: Ministry of Public HealthRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSpain: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Placebo
Placebo single oral dose (first 8 hours)
• Dexketoprofen-single dose
Dexketoprofen single oral dose (first 8 hours)
• Tramadol-single dose
Tramadol single oral dose (first 8 hours)
• Dexketoprofen/Tramadol-single dose
Dexketoprofen/Tramadol single oral dose (first 8 hours)
• Dexketoprofen-multiple doses
Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
• Tramadol-multiple doses
Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
• Dexketoprofen/Tramadol-multiple doses
Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Locations

Country	Name	City	State
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	University Hospital of Debrecen	Debrecen
Hungary	Fejér megyei Szent György Kórház	Székesfehérvár
Hungary	Dr. Bugyi István Kórház	Szentes
Latvia	Juras Medicinas Centre	Riga
Latvia	Riga East University Hospital Gynecology Clinic	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas	Kaunas
Lithuania	Vilniaus gimdymo namai	Vilnius
Poland	Prywatna Klinika Polozniczo-Ginekologiczna	Bialystok
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1	Lublin	Lubelskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie	Lublin	Lubelskie
Poland	Ginekologiczno-Polozniczy Szpital Kliniczny UM w Poznaniu	Poznan
Poland	Wojewodzki Szpital	Przemysl
Poland	Specjalistyczny Szpital im. E. Szczeklika	Tarnow
Poland	Centralny Szpital Kliniczny MSW w Warszawie	Warszawa
Poland	Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Mini	Warszawa
Romania	Genesys Fertility Center	Bucharest
Romania	Institutul pentru Ocrotirea Mamei si Copilului (IOMC) "Prof. Dr. Alfred Rusescu"	Bucharest
Romania	Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie I	Bucharest
Romania	Spitalul Clinic "Dr. Ioan Cantacuzino" - Sectia Clinica Obstetrica Ginecologie II	Bucharest
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucharest
Romania	Spitalul Clinic de Urgenta "Sfantul Pantelimon"	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Obstretica Ginecologie I	Targu-Mures
Russian Federation	Moscow Regional Research Institute of Obstetrics and Gynecol	Moscow
Russian Federation	FGUZ Clinical Hospital 122 n.a. L.G. Sokolova FMBA	Saint Petersburg
Slovakia	GYNPOR, s.r.o.	Sliac
Spain	Complejo Hospitalario Arquitecto Marcide	Ferrol
Spain	Hospital Universitario Arnau de Vilanova	Lérida

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Countries where clinical trial is conducted

Hungary,  Latvia,  Lithuania,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain, 

References & Publications (1)

Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fülesdi B, Nizzardo A, Guerrero-Bayón C, Cuadripani S, Pizà-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPID8 (Sum of Pain Intensity Differences Over 8 Hours)	Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.; The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.	over 8 hours after the first dose	No
Secondary	Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)	Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.; The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.	over 8 hours after first dose	No
Secondary	SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)	Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.; PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.; The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.	over 48 hours of the multiple-dose phase	No
Secondary	Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)	Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.; The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.	over 48 hours of the multiple-dose phase	No

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