A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Tramadol HCl/Acetaminophen ER; Tramadol HCl/Acetaminophen IR
Intervention description: 2 tablets of ER (tramadol HCl [75 mg]/acetaminophen [650 mg]) will be administered at 0, 12, 24 and 36 hours; 2 tablets of IR (tramadol HCl [37.5 mg]/acetaminophen [325 mg]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 320.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain, Postoperative; Tramadol Hydrochloride; Acetaminophen; Ultracet

Summary:

      The purpose of this study is to compare the efficacy and safety of extended release (ER)
      tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol
      HCl/acetaminophen in participants with moderate to severe (very serious, life threatening)
      postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are scheduled to have standard primary (non-revision) unilateral
             (having to do with only 1 side of a structure) total knee replacement arthroplasty
             (TKRA-surgery to fix a joint) for non-inflammatory (no swelling, redness, and pain in
             tissues caused by injury or damage) degenerative joint disease (NIDJD)

          -  Participants who are capable of oral (having to do with the mouth) intake

          -  Women must be: postmenopausal (for at least 1 year), surgically sterile, abstinent
             (not having sexual intercourse), or practicing a highly effective method of birth
             control before participation in the study and who agree to continue to use the same
             method of birth control throughout the study in cases of women of childbearing
             potential

          -  Male participants must practice contraception, and must agree not to donate his sperms
             for 1 month after the last dose of study drug

          -  Participants who will complain of baseline pain of intensity of greater than or equal
             to 4 on 11-point numeric rating scale (NRS) measured within 1 hour prior to
             randomization (study drug assigned by chance) and a maximum of 6 hours after
             discontinuation of participant controlled analgesia (PCA) after at least 12 hours of
             application following TKRA

        Exclusion Criteria:

          -  Participants with Illness history (severe [very serious, life threatening] hepatic
             [having to do with the liver] failure, severe renal [having to do with the kidney]
             failure; severe respiratory depression; risk for mental fog with head injury or brain
             lesions [abnormal area of tissue, such as a wound, sore, rash, or boil]; digestive
             ulcer [sore], severe blood abnormalities; severe cardiac insufficiency; aspirin asthma
             [asthmatic attack-breathing disorder in which there is a wheezing and difficulty in
             breathing; caused by non-steroidal anti-inflammatory drugs] or history of aspirin
             asthma; history of epilepsy [seizure disorder]; rheumatism, significant psychiatric
             disorder or taking antipsychotic drugs for psychiatric treatment)

          -  Administration of disallowed therapy such as: administration of oral, patch, injection
             or local analgesics (drug used to control pain) acting centrally (the brain and the
             spinal cord) or peripherally (not central) before study drug administration after
             completion of PCA application, surgery is conducted simultaneously in addition to
             TKRA, administration of monoamine oxidase (MAO) inhibitors or discontinuation of the
             administration within 2 weeks, tricyclic antidepressants that may increase the seizure
             (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal
             brain function) risk when concomitantly (given at the same time) administered,
             neuroleptics, or drugs that may lower the seizure threshold, use of sedatives (a
             medication to calm or make less anxious) other than that used for general anesthesia
             (loss of sensation or feeling) during surgery

          -  Participants who used any study drug or investigational medical device within 30 days
             before the start of the treatment

          -  Participants requiring postoperative intensive care unit (ICU) care

          -  Participants having hypersensitivity to tramadol or acetaminophen