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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This study is a randomized (study drug assigned by chance), multicenter (when more than 1
      hospital or medical school team work on a medical research study), active-controlled,
      parallel group (each group of participants will be treated at the same time), double-blind
      (neither physician nor participant knows the treatment that the participant receives) study.
      The duration of the treatment will be 2 days and will be conducted in 4 periods: screening
      period (from 33 to 2 days before study drug administration to the first surgical incision),
      surgical period (to 1 day before study drug administration), qualification period (1 day) and
      double-blind treatment period (1 to 2 days). Participants will be randomly assigned to 2
      groups: study drug treatment group (ER) and comparator treatment group (IR). Participants
      will be administered 2 tablets of ER tramadol HCl (75 milligram [mg])/acetaminophen (650 mg)
      along with 2 tablets of placebo matching to IR tramadol HCl/acetaminophen in study drug
      treatment group; and 2 tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) along with
      2 tablets of placebo matching to ER tramadol HCl/acetaminophen in comparator treatment group
      respectively at 0, 12, 24 and 36 hours. Participants will also be administered 2 tablets of
      placebo matching to IR tramadol HCl/acetaminophen in study drug treatment group; and 2
      tablets of IR tramadol HCl/acetaminophen in comparator treatment group respectively at 6, 18,
      30 and 42 hours. Participants will be administered investigational product at 6-hour interval
      from the time of the first investigational product administration over 48 hours. Efficacy
      will be assessed using 11-point numeric rating scale (NRS). Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Tramadol HCl/Acetaminophen ER; Tramadol HCl/Acetaminophen IR
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Ultracet; Ultracet
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain, Postoperative; Tramadol Hydrochloride; Acetaminophen; Ultracet