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
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