Status:
COMPLETED
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Lead Sponsor:
Menarini Group
Conditions:
Acute Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 age...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
641 Patients enrolled
Trial Details
Trial ID
NCT01902134
Start Date
April 1 2013
End Date
February 1 2014
Last Update
March 7 2016
Active Locations (37)
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1
Fakultni nemocnice Brno
Brno, Czechia, 625 00
2
Urazova nemocnice v Brne
Brno, Czechia, 662 50
3
Nemocnice Jihlava, p.o.
Jihlava, Czechia, 586 33
4
Oblastni nemocnice Kladno
Kladno, Czechia, 272 59