A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety.
Condition: Arthralgia; Bunion; Hallux Valgus; Pain Assessment; Tapentadol
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 3 different dose levels of CG5503 compared with oxycodone and with
      placebo in patients who have had a bunionectomy, and to assess the safety of the drug for 9
      days after patients are discharged from the hospital.
    

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, addiction, tolerance, and respiratory depression. CG5503, a newly
      synthesized drug 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 3 dose levels of CG5503 Immediate Release (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 (patients are assigned different treatments based on
      chance), 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 phase immediately following bunionectomy, during which patients will be treated
      with either 50-, 75-, or 100-mg CG5503 IR base, a placebo, or 15-mg oxycodone IR, and pain
      intensity and pain relief will be periodically assessed. Following this phase, patients
      wishing to continue treatment with CG5503 IR may enter an outpatient voluntary nonrandomized,
      open-label extension phase for 9 days when they will receive 50- or 100-mg CG5503 IR.
      Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief
      numeric rating scale (PAR), and patient global impression of change scale (PGIC). 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 CG5503 and oxycodone. The null hypothesis for the study is that efficacy
      results for all CG5503 IR dosage groups are equal to placebo based on the mean sum of pain
      intensity difference at 48 hours. The alternative study hypothesis is that at least 1 dose
      strength of CG5503 will be different from placebo in controlling pain at 48 hours. CG5503 IR
      50, or 75, or 100 mg (of the base), or oxycodone 15 mg, or placebo: 1 capsule taken every 4
      to 6 hours during the 72-hour postsurgery phase of the study; and CG5503, 50 mg capsules, 1
      to 2 tablets taken by mouth every 4 to 6 hours for up to 9 days during the open label portion
      of the study. All doses of study treatment will be taken with approximately 120 mL of water
      with or without food.
    

Intervention name(s): CG5503 IR;tapentadol
Intervention type(s): Drug
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute pain; bunionectomy