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

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01063842
First received: October 8, 2009
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: tramadol hydrochloride /acetaminophen
Drug: tramadol hydrochloride / acetaminophen and placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tolerability Improvement of Tramadol/Acetaminophen (Ultracet) by Titration in Korean OA Patients:Multicenter, Randomized, Double-blind Study

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Study Discontinuation rate due to adverse event [ Time Frame: Throughout the study from start of study drug until final visit, Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison of the pain intensity scores between the 2 treatment groups [ Time Frame: Day 0, Day 14 ] [ Designated as safety issue: No ]
  • comparison of the pain relief scores between the 2 treatment groups [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • comparison of the overall assessment of patient between the 2 treatment groups [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • comparison of the overall assessment of investigator between the 2 treatment groups [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: August 2005
Study Completion Date: May 2006
Arms Assigned Interventions
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
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
Active Comparator: 002
tramadol hydrochloride /acetaminophen 1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.
Drug: tramadol hydrochloride /acetaminophen
1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063842

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Medical Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01063842     History of Changes
Other Study ID Numbers: CR004990
Study First Received: October 8, 2009
Last Updated: February 4, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Drop-out rate
Osteoarthritis
Tolerability
Tramadol
Acetaminophen

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Tramadol
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Antipyretics
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014