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

NCT ID: NCT01902134

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-02-28

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 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty 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 oral single dose (first 8 hours)

Dexketoprofen/Tramadol-multiple doses

Intervention Type: DRUG

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

Interventions

Placebo

Placebo single oral dose (first 8 hours)

Intervention Type: DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

Intervention Type: DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

Intervention Type: DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol oral single dose (first 8 hours)

Intervention Type: DRUG

Tramadol-multiple doses

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

Intervention Type: DRUG

Dexketoprofen-multiple doses

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

Intervention Type: DRUG

Dexketoprofen/Tramadol-multiple doses

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.
• Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.
• 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.
• Pregnant and breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Moore, Professor

Role: STUDY_CHAIR

Pain Research & Nuffield Department of Anaesthetics - University of Oxford

Henry J McQuay, Professor

Role: STUDY_CHAIR

Balliol College Oxford

Locations

Fakultni nemocnice Brno

Brno, , Czechia

Urazova nemocnice v Brne

Brno, , Czechia

Nemocnice Jihlava, p.o.

Jihlava, , Czechia

Oblastni nemocnice Kladno

Kladno, , Czechia

Oblastni nemocnice Mlada Boleslav a.s.

Mladá Boleslav, , Czechia

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, , Germany

Uzsoki Hospital, Department of Orthopaedics

Budapest, , Hungary

University of Debrecen

Debrecen, , Hungary

PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze

Pécs, , Hungary

Fejér Megyei Szent György Kórház

Székesfehérvár, , Hungary

MÁV Kórház és Rendelőintézet, Ortopédiai osztály

Szolnok, , Hungary

Liepaja Regional Hospital

Liepāja, , Latvia

Riga's 2nd Hospital

Riga, , Latvia

Hospital of Traumatology and Orthopaedics

Riga, , Latvia

Vidzemes Hospital

Valmiera, , Latvia

Kaunas Clinical Hospital

Kaunas, , Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, , Lithuania

Klaipedos Universitetine ligonine

Klaipėda, , Lithuania

Respublikine Vilniaus universitetine ligonine

Vilnius, , Lithuania

Uniwersytecki Szpital Klioniczny w Bialymstoku

Bialystok, , Poland

Warminskie Centrum Ortopedyczne

Elblag, , Poland

Wojewodzki Szpital Specjalistyczny

Lublin, , Poland

Specjalistyczny Szpital im. E. Szczeklika

Tarnów, , Poland

Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu

Wroclaw, , Poland

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

Clinical Center of Serbia

Belgrade, , Serbia

Institute for orthopedic Surgery Banjica [Ortopedic Surgery

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica

Niš, , Serbia

Hospital L'Esperança. Parc de Salut Mar.

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

China Medical University Hospital [Orthopedic]

Taichung, , Taiwan

Kuang Tien General Hospital

Taichung, , Taiwan

Cherkaska oblasna likarnia

Cherkasy, , Ukraine

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

Kharkiv, , Ukraine

Kyivska oblasna klinichna likarnia

Kyiv, , Ukraine

Sevastopolska miska likarnia №9

Sevastopol, , Ukraine

Countries

Czechia; Germany; Hungary; Latvia; Lithuania; Poland; Serbia; Spain; Taiwan; Ukraine

References

McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.

Reference Type: RESULT

PMID: 26787797 (View on PubMed)

Other Identifiers

2012-004548-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEX-TRA-05

Identifier Type: -

Identifier Source: org_study_id