Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01063842
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : February 5, 2010
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date  ICMJE October 8, 2009
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date February 5, 2010
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
Study Discontinuation rate due to adverse event [ Time Frame: Throughout the study from start of study drug until final visit, Day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • comparison of the pain intensity scores between the 2 treatment groups [ Time Frame: Day 0, Day 14 ]
  • comparison of the pain relief scores between the 2 treatment groups [ Time Frame: Day 14 ]
  • comparison of the WOMAC (Western and Ontario Mcmaster) total scores between the 2 treatment groups.The WOMAC index is a 24-item questionnaire completed by the patient and focusing on pain, stiffness and function related to osteoarthritis of knee and hip [ Time Frame: Day 0, Day 14 ]
  • comparison of the overall assessment of patient between the 2 treatment groups [ Time Frame: Day 14 ]
  • comparison of the overall assessment of investigator between the 2 treatment groups [ Time Frame: Day 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis
Official Title  ICMJE Tolerability Improvement of Tramadol/Acetaminophen (Ultracet) by Titration in Korean OA Patients:Multicenter, Randomized, Double-blind Study
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: tramadol hydrochloride /acetaminophen
    1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.
  • Drug: tramadol hydrochloride / acetaminophen and placebo
    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
Study Arms  ICMJE
  • Experimental: 001
    tramadol hydrochloride / acetaminophen and placebo 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: Drug: tramadol hydrochloride / acetaminophen and placebo
  • Active Comparator: 002
    tramadol hydrochloride /acetaminophen 1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.
    Intervention: Drug: tramadol hydrochloride /acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2010)
250
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have osteoarthritis of the knee for at least one year based on clinical and radiological criteria
  • Must have been on a stable daily dose of a NSAID for at least two weeks prior to randomization
  • Must have a pain intensity Numeric Rating Scale (NRS) score 4 or more as a average intensity for 48 hours. (On a Numeric Rating Scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)

Exclusion Criteria:

  • Have taken tramadol HCL within 14 days prior to randomization
  • Have taken acetaminophen within 7 days prior to randomization
  • Have received other pain medication (including topical medication and/or anesthetics), sedative hypnotics, or muscle relaxants within a period of less than five half-lives of the given medication prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01063842
Other Study ID Numbers  ICMJE CR004990
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Director, Janssen Korea, Ltd., Korea
Study Sponsor  ICMJE Janssen Korea, Ltd., Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
PRS Account Janssen Korea, Ltd., Korea
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP