A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol
      immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain,
      compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.
    

Detailed description: 
      Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of
      the joint at the base of the big toe comprised of bone and soft tissue) often experience
      moderate to severe acute pain post-surgery. Normally such pain is controlled when patients
      receive repeated doses of opioid analgesics. Tapentadol (CG5503) is a newly synthesized
      opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different
      mode of action. This study, a randomized (patients are assigned different treatments based on
      chance), double-blind (neither investigator nor patient knows which treatment the patient
      receives), placebo-controlled (placebo is an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial), parallel-group (each group
      of patients will be treated at the same time), multicenter study (the study is performed at
      more than one clinic) is designed to evaluate the effectiveness (level of pain control) and
      safety (side effects) of tapentadol immediate-release (IR) 50 mg or 75 mg versus placebo. The
      study will consist of a screening phase, during which the patients will be evaluated for
      study entry (Days -28 to -2) followed by the surgical period (Day -1) during which the
      bunionectomy will be performed and which will start with the first surgical incision and
      continues until termination of the popliteal sciatic block (PSB) infusion. During the
      qualification period (Day 1) which starts after termination of the post-operative continuous
      PSB infusion, patients will be evaluated for entry in the double blind treatment phase.
      Patients will be randomly assigned to one of three treatment groups to receive either 50 mg
      tapentadol IR, 75 mg tapentadol IR or a placebo if their PI is equal to or greater than 4 on
      a 0-10 numerical rating scale. The inpatient double-blind treatment period will be 72 hours
      in duration and will include a final end-of-double-blind evaluation (on Day 4, i.e., 72 hours
      after the administration of the first dose) for all patients. Any patient requiring analgesia
      for pain relief in addition to study drug during the double-blind treatment period will be
      discontinued from the study due to lack of efficacy. All patients who discontinue for lack of
      efficacy will complete pain assessments and the Patient Global Impression of Change (PGIC)
      before receiving rescue medication. Pain intensity and pain relief will be periodically
      assessed during the treatment period using rating scales. Safety evaluations include
      monitoring of adverse events, physical examinations, and clinical laboratory tests. The study
      length, including the screening period, will be up to a maximum duration of 32 days.
    

Intervention name(s): Tapentadol IR 50 mg; Tapentadol IR 75 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.; Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.; Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bunionectomy; Acute pain; Post-operative pain; Tapentadol IR; Analgesia; Hallux valgus