A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the number of osteoarthritis patients receiving
      titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet
      (titration group) who discontinue treatment due to adverse events to the number of patients
      receiving a non-titrated dose of tramadol/hydrochloride/acetaminophen combination tablet who
      discontinue treatment due to adverse events.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), multicenter, double-blind (neither
      physician nor patient knows the name of the assigned drug), add-on study (NSAIDs or COX-2
      medications maintained at pre-study dose.) to investigate the tolerability of titrated doses
      of tramadol hydrochloride/acetaminophen combination tablet in osteoarthritis patients taking
      NSAIDS or COX-2 inhibitors (both are drugs used to treat inflammation and pain) compared to
      non-titrated doses of tramadol hydrochloride/acetaminophen combination tablet. The patients
      will be randomized into 2 treatment groups. First group (the titration group) receives 1
      tablet of tramadol hydrochloride/acetaminophen in the morning, 1 tablet of placebo in the
      afternoon and evening for 3 days, then 1 tablet of tramadol hydrochloride/acetaminophen in
      the morning, 1 tablet of placebo in the afternoon and 1 tablet of tramadol
      hydrochloride/acetaminophen in the evening for 4 days, and the 1 tablet of tramadol
      hydrochloride/acetaminophen three times daily for next 7 days. The second group
      (non-titration group) will receive 1 tablet of tramadol hydrochloride/acetaminophen three
      times daily without titration for 14 days. The study hypothesis is the first group's
      discontinuation rate due to adverse events is lower than that of second group. Safety
      assessments include adverse event, vital sign and clinical lab monitoring. First group will
      receive 1 tablet of tramadol hydrochloride/acetaminophen and 2 tablets of placebo for 3 days,
      2 tablets of tramadol hydrochloride/acetaminophen and 1 tablet of placebo for 4 days, and 3
      tablets of tramadol hydrochloride/acetaminophen for 7 days. Second group will receive 3
      tablets of tramadol hydrochloride/acetaminophen for 14 days.
    

Intervention name(s): tramadol hydrochloride /acetaminophen; tramadol hydrochloride / acetaminophen and placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.; 1 tablet of tramadol/acetaminophen in the morning, 1 tablet of placebo in the afternoon and evening for 3 days, then 1 tablet of tramadol/acetaminophen in the morning, evening and 1 tablet of placebo in the afternoon for 4 days, then 1 tablet of tramadol/acetaminophen 3 times daily for next 7 days
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Drop-out rate; Osteoarthritis; Tolerability; Tramadol; Acetaminophen