Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Placebo; Tramadol-single dose; Dexketoprofen-single dose; Dexketoprofen/Tramadol-single dose; Tramadol-multiple doses; Dexketoprofen-multiple doses; Dexketoprofen/Tramadol-multiple doses
Intervention description: Placebo single oral dose (first 8 hours); Tramadol single oral dose (first 8 hours); Dexketoprofen single oral dose (first 8 hours); Dexketoprofen/Tramadol oral single dose (first 8 hours); Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses); Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses); Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
Intervention MeSH terms: Dexketoprofen trometamol; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 641.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Moderate to severe acute pain; Postoperative pain; Hip arthroplasty; Analgesics; Dexketoprofen; Tramadol

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.
    

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.