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
Intervention: Tapentadol IR 50 mg; Tapentadol IR 75 mg; Placebo
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bunionectomy; Acute pain; Post-operative pain; Tapentadol IR; Analgesia; Hallux valgus

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be undergoing primary unilateral first metatarsal bunionectomy that
             includes a distal Chevron osteotomy only, with or without the Akin procedure

          -  Patients must be healthy or medically stable on the basis of clinical laboratory tests
             performed at screening

          -  Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to
             practice an effective method of birth control and have a negative serum pregnancy test
             at screening and a negative urine pregnancy test before surgery

          -  If a male, must use an approved method of birth control and does not donate sperm from
             the day of study drug administration until 3 months afterwards

          -  Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an
             11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier
             than 10 hours after the first surgical incision and within 9 hours after termination
             of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History
             of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of
             unconsciousness of more than 24 hours duration, malignancy in the past 2 years with
             the exception of successfully treated basal cell carcinoma

          -  Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain
             neoplasm within 1 year of screening

          -  Renal insufficiency, impaired hepatic function

          -  Use of anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic
             antidepressants (TCAs), neuroleptics, serotonin norepinephrine reuptake inhibitors
             (SNRIs), selective serotonin reuptake inhibitors (SSRIs) or triptans