A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Acute Pain
Intervention: Tapentadol IR 50 mg; Tapentadol IR 75 mg; Placebo
Intervention description: Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.; Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.; Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 353.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hallux Valgus; Bunionectomy; Bunion; Acute pain; Tapentadol; Tapentadol IR

Summary:

      The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR
      50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours
      (SPID48) to measure analgesic effect in Korean patients with acute pain following
      bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are undergoing primary unilateral first metatarsal bunionectomy that
             includes a distal Chevron osteotomy only with or without the Akin procedure

          -  Healthy or medically stable on the basis of clinical laboratory tests performed at
             screening. If results are outside the normal reference ranges, the patient may be
             included only if the investigator judges the abnormalities or deviations from normal
             to be not clinically significant or to be appropriate and reasonable for the
             population under study

          -  Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to
             practice an effective method of birth control if they are sexually active before entry
             and throughout the study. Women of childbearing potential must have a negative serum β
             human chorionic gonadotropin pregnancy test at screening and a negative urine
             pregnancy test before surgery

          -  If a male and sexually active, agrees to use an approved method of birth control to
             prevent pregnancy in his female partner and not to donate sperm from the day of first
             study drug intake until 3 months after the day of last study drug intake. To qualify
             for entry into the double-blind treatment period, the following criteria must be met:

          -  Qualifying baseline pain intensity (PI) must be rated as greater than or equal to 4 on
             an 11-point (0 to10) PI numerical rating scale (NRS), recorded within 30 minutes
             before randomization

          -  Qualifying PI must occur no earlier than 10 hours after the first surgical incision

          -  Qualifying baseline PI must occur within 9 hours after termination of the systemic
             analgesia during the postoperative surgical period

        Exclusion Criteria:

          -  History of seizure disorder or epilepsy suggested by the presence of mild or moderate
             traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1
             year of screening, and/or severe traumatic brain injury, episode(s) of unconsciousness
             of more than 24 hours duration, or posttraumatic amnesia of more than 24 hours
             duration within 15 years of screening

          -  History of malignancy within the past 2 years before the start of the study

          -  Evidence of active infections that may spread to other areas of the body or a history
             of human immunodeficiency virus 1 or 2

          -  Clinical laboratory values reflecting severe renal insufficiency

          -  Moderately or severely impaired hepatic function, or patients with abnormal alanine
             aminotransaminase or aspartate aminotransferase

          -  Clinical laboratory values outside acceptable limits for surgery in the opinion of the
             investigator

          -  A clinically significant disease that in the investigator's opinion may affect
             efficacy or safety assessments

          -  Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants,
             neuroleptics, or serotonin norepinephrine reuptake inhibitor within 2 weeks before
             randomization

          -  Systemic steroid therapy, excluding inhalers or topical steroids, within the 4 weeks
             before screening

          -  Women who plan to become pregnant during the study, or who are breast feeding