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

Summary: 
      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of 2 different dose levels of tapentadol (CG5503) compared with
      oxycodone and with placebo in subjects who have had a bunionectomy.
    

Detailed description: 
      Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery.
      Normally such pain is controlled when patients receive repeated doses of opioid analgesics.
      However, opioid therapy is commonly associated with side effects such as nausea, vomiting,
      sedation, constipation, and less frequently, respiratory depression. Tapentadol (CG5503), a
      newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally
      acting analgesic but has a dual mode of action. The aim of this study is to investigate the
      effectiveness (level of pain control) and safety (side effects) of 2 dose levels of
      tapentadol (CG5503) IR compared to no drug (placebo) or one dose level of oxycodone (an
      opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind
      (neither investigator nor patient will know which treatment is received), active- and
      placebo-controlled, parallel-group, multicenter study to evaluate treatment of the acute pain
      from bunionectomy. The study will include a blinded 72 hour inpatient (the patient will stay
      in the facility where the procedure is done) phase immediately following bunionectomy, during
      which patients will be treated with either 50- or 75-mg tapentadol (CG5503) IR, a placebo, or
      10-mg oxycodone IR, and pain relief will be periodically assessed. Assessments of pain
      intensity (PI) and pain relief (PAR) are obtained using the numerical rating scale, and the
      patient global impression of change scale (PGIC) will measure overall patient status. Safety
      evaluations include monitoring of adverse events, physical examinations, and clinical
      laboratory tests. Venous blood samples will be collected for the determination of serum
      concentrations of tapentadol (CG5503) and oxycodone. The study hypotheses are that at least
      one tapentadol (CG5503) IR dose will be different from placebo in controlling patients pain
      at 48 hours, followed by establishing that at least one tapentadol (CG5503) IR dose will be
      non-inferior compared with oxycodone IR (oxycodone IR is not clinically significantly better
      than a tapentadol (CG5503) IR dose). A comparison of the incidence rate of the adverse events
      of nausea and/or vomiting, and the incidence rate of the adverse event of constipation,
      between tapentadol (CG5503) IR and oxycodone IR will also be performed. Tapentadol (CG5503)
      IR 50 or 75 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours
      during the 72-hour postsurgery phase of the study (acetaminophen is also allowed during the
      first 12 hours on Day 1, if needed for pain). All doses of study treatment will be taken with
      approximately 120 mL of water with or without food.
    

Intervention name(s): Tapentadol (CG5503); Tapentadol (CG5503); oxycodone; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg capsule q4-6 hrs for 3 days; 75mg capsule q4-6 hrs for 3 days; 10mg capsule q4-6 hrs for 3 days; 1 capsule q4-6 hrs for 3 days
Intervention MeSH terms: Oxycodone; Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute pain; bunionectomy; tapentadol