A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Condition: Hysterectomy; Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to demonstrate the efficacy and safety of multiple-dose
      application of three different oral doses of CG5503 IR (tapentadol immediate release)
      compared to placebo in women undergoing abdominal hysterectomy.
    

Detailed description: 
      Subjects undergoing abdominal hysterectomy 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.
      Tapentadol (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
      study is to investigate the effectiveness (level of pain control) and safety (side effects)
      of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine
      (an opioid commonly used to treat post-surgical pain). This study is a randomized,
      double-blind (neither investigator nor patient will know which treatment was received),
      active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment
      of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour
      in-patient phase immediately following hysterectomy, during which subjects will be treated
      with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-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 study
      hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in
      controlling pain at 24 hours (using the mean SPID at 24 hours).
    

Intervention name(s): Morphine; CG5503 IR; CG5503 IR; CG5503 IR; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg IR; 4 - 6 hourly; Total 72 hours; 50mg; 4 - 6 hourly; Total 72 hours; 75mg; 4 -6 hourly; Total 72 hours; 100mg, 4 - 6 hourly; Total 72 hours; 4 - 6 hourly; Total 72 hours
Other intervention name(s): Tapentadol; Tapentadol; Tapentadol
Intervention MeSH terms: Morphine; Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Opioid; Central acting analgesic; Pain postoperative; Abdomen acute; CG5503 IR; Morphine; Placebo