Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (DAVID-art)
Acute Pain
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Moderate to severe acute pain, Postoperative pain, Hip arthroplasty, Analgesics, Dexketoprofen, Tramadol
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.
Sites / Locations
- Fakultni nemocnice Brno
- Urazova nemocnice v Brne
- Nemocnice Jihlava, p.o.
- Oblastni nemocnice Kladno
- Oblastni nemocnice Mlada Boleslav a.s.
- Klinikum Frankfurt Höchst GmbH
- Uzsoki Hospital, Department of Orthopaedics
- University of Debrecen
- PTE KK Trauma Központ-Balesetsebészeti és Kézsebésze
- MÁV Kórház és Rendelőintézet, Ortopédiai osztály
- Fejér Megyei Szent György Kórház
- Liepaja Regional Hospital
- Riga's 2nd Hospital
- Hospital of Traumatology and Orthopaedics
- Vidzemes Hospital
- Kaunas Clinical Hospital
- Hospital of Lithuanian University of Health Sciences Kaunas
- Klaipedos Universitetine ligonine
- Respublikine Vilniaus universitetine ligonine
- Uniwersytecki Szpital Klioniczny w Bialymstoku
- Warminskie Centrum Ortopedyczne
- Wojewodzki Szpital Specjalistyczny
- Specjalistyczny Szpital im. E. Szczeklika
- Urazowo - Ortopedycznej Wojewodzkiego Szpitala Specjalistycznego we Wrocławiu
- Medical University of Lodz
- Clinical Center of Serbia
- Institute for orthopedic Surgery Banjica [Ortopedic Surgery
- Clinical Center Kragujevac
- Clinic for Orthopedic Surgery and Trauma Bul. Dr Zorana Djindjica
- Hospital L'Esperança. Parc de Salut Mar.
- Hospital Universitario Puerta del Mar
- China Medical University Hospital [Orthopedic]
- Kuang Tien General Hospital
- Cherkaska oblasna likarnia
- Instytut patologii khrebta ta suglobiv im. prof. M.I. Sytenka NAMN Ukraine
- Kyivska oblasna klinichna likarnia
- Sevastopolska miska likarnia №9
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Active Comparator
Other
Other
Other
DKP/TRAM followed by DKP/TRAM
DKP followed by DKP
TRAM followed by TRAM
Placebo followed by DKP/TRAM
Placebo followed by DKP
Placebo followed by TRAM
Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
Tramadol-single dose followed by Tramadol-multiple doses
Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
Placebo single dose followed by Dexketoprofen-multiple doses
Placebo single dose followed by Tramadol-multiple doses