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

Information source: Menarini Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pain

Intervention: Placebo (Drug); Tramadol-single dose (Drug); Dexketoprofen-single dose (Drug); Dexketoprofen/Tramadol-single dose (Drug); Tramadol-multiple doses (Drug); Dexketoprofen-multiple doses (Drug); Dexketoprofen/Tramadol-multiple doses (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Menarini Group

Official(s) and/or principal investigator(s):
Andrew Moore, Professor, Study Chair, Affiliation: Pain Research & Nuffield Department of Anaesthetics - University of Oxford
Henry J McQuay, Professor, Study Chair, Affiliation: Balliol College Oxford

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.

Clinical Details

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 After Elective Unilateral Total Hip Arthroplasty

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

Primary outcome: SPID8 (Sum of Pain Intensity Differences Over 8 Hours)

Secondary outcome:

SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)

Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)

Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Fakultni nemocnice Brno, Brno 625 00, Czech Republic

Urazova nemocnice v Brne, Brno 662 50, Czech Republic

Nemocnice Jihlava, p.o., Jihlava 586 33, Czech Republic

Oblastni nemocnice Kladno, Kladno 272 59, Czech Republic

Oblastni nemocnice Mlada Boleslav a.s., Mlada Boleslav 293 50, Czech Republic

Klinikum Frankfurt Höchst GmbH, Frankfurt am Main 65929, Germany

Uzsoki Hospital, Department of Orthopaedics, Budapest 1145, Hungary

University of Debrecen, Debrecen H-4012, Hungary

PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze, Pécs 7632, Hungary

MÁV Kórház és Rendelőintézet, Ortopédiai osztály, Szolnok 5000, Hungary

Fejér Megyei Szent György Kórház, Székesfehérvár 8000, Hungary

Liepaja Regional Hospital, Liepaja LV-3414, Latvia

Hospital of Traumatology and Orthopaedics, Riga LV-1005, Latvia

Riga's 2nd Hospital, Riga LV-1004, Latvia

Vidzemes Hospital, Valmiera LV-4201, Latvia

Hospital of Lithuanian University of Health Sciences Kaunas, Kaunas LT-50009, Lithuania

Kaunas Clinical Hospital, Kaunas LT-44320, Lithuania

Klaipedos Universitetine ligonine, Klaipeda 92288, Lithuania

Respublikine Vilniaus universitetine ligonine, Vilnius LT-04130, Lithuania

Uniwersytecki Szpital Klioniczny w Bialymstoku, Bialystok 15-276, Poland

Warminskie Centrum Ortopedyczne, Elblag 82-300, Poland

Wojewodzki Szpital Specjalistyczny, Lublin 20-718, Poland

Specjalistyczny Szpital im. E. Szczeklika, Tarnow 33-100, Poland

Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu, Wroclaw 51-128, Poland

Clinical Center of Serbia, Belgrade 11000, Serbia

Institute for orthopedic Surgery Banjica [Ortopedic Surgery, Belgrade 11000, Serbia

Clinical Center Kragujevac, Kragujevac 34000, Serbia

Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica, Nis 18000, Serbia

Hospital L'Esperança. Parc de Salut Mar., Barcelona 08024, Spain

Hospital Universitario Puerta del Mar, Cadiz 11009, Spain

China Medical University Hospital [Orthopedic], Taichung 404, Taiwan

Kuang Tien General Hospital, Taichung 433, Taiwan

Cherkaska oblasna likarnia, Cherkasy 18009, Ukraine

Instytut patologii khrebta ta suglobiv im. prof. M.I. Sytenka NAMN Ukraine, Kharkiv 61024, Ukraine

Kyivska oblasna klinichna likarnia, Kyiv 04107, Ukraine

Sevastopolska miska likarnia №9, Sevastopol 99018, Ukraine

Medical University of Lodz, Lodz, Łódzkie 91-002, Poland

Additional Information

Starting date: April 2013
Last updated: April 3, 2015

Page last updated: August 23, 2015

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