Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Menarini Group
Treatments:
Analgesics
Dexketoprofen trometamol
Ketoprofen
Tramadol
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.