A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Condition: Bunionectomy; Pain; Postoperative Pain; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose
      application of oral application of CG5503 IR 75mg compared to placebo and to assess safety
      and tolerability of CG5503 IR 75mg in subjects following bunionectomy.

      This trial was performed based on a previously performed double-blind, placebo-controlled,
      multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75
      and 100 mg) published under PMID: 18851776.
    

Detailed description: 
      Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery.
      Normally such pain is controlled when subjects 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 with an immediate release (IR) formulation, also acts as a centrally acting
      pain reliever but has a dual mode of action. The aim of this trial is to investigate the
      effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared
      with no drug (placebo) or one dose of morphine (an opioid commonly used to treat
      post-surgical pain). This trial is a randomized, double-blind (neither investigator nor
      patient will know which treatment was received), active- and placebo-controlled,
      parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy.
      The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy,
      during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg
      morphine, and pain relief will be periodically assessed. 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 morphine. The
      alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different
      from placebo in controlling pain at 48 hours.
    

Intervention name(s): CG5503 IR; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75mg IR 4 - 6 hourly Total: 72 hours; Morphine 30 mg IR 4 - 6 hourly Total: 72 hours; Placebo; 4 - 6 hourly; Total: 72 hours
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid; Central acting analgesic; CG5503 IR; Postoperative pain; Bunionectomy; Morphine; Placebo