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A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00635349
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : June 24, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Tracking Information
First Submitted Date  ICMJE March 6, 2008
First Posted Date  ICMJE March 13, 2008
Results First Submitted Date  ICMJE May 2, 2013
Results First Posted Date  ICMJE June 24, 2013
Last Update Posted Date July 22, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 [ Time Frame: Day 29 and Day 85 ]
The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
WOMAC total score: Day 85 - Day 29 (randomization)
Change History Complete list of historical versions of study NCT00635349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • Change From Day 29 in Pain Intensity Score at Day 85 [ Time Frame: Day 29 and Day 85 ]
    Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.
  • Number of Participants With Pain Relief [ Time Frame: Day 29, Day 57 and Day 85 ]
    Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.
  • Number of Participants With Overall Assessment on Study Drug by Participants [ Time Frame: Day 85 ]
    Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
  • Number of Participants With Overall Assessment on Study Drug by Investigator [ Time Frame: Day 85 ]
    Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
  • Number of Participants With Categorical Swelling [ Time Frame: Day 29, Day 57 and Day 85 ]
    Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).
  • Number of Participants With Categorical Tenderness [ Time Frame: Day 29, Day 57 and Day 85 ]
    Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Pain intensity, pain relief, subject's and investigator's overall evaluation on the study medication, swelling and tenderness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
Official Title  ICMJE A Comparison of Tramadol/Acetaminophen Tablets Maintenance Versus NSAID Maintenance After Tramadol/Acetaminophen and NSAID Combination Therapy in Knee Osteoarthritis Patients: Multicenter, Randomized, Open Comparative Study
Brief Summary The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.
Detailed Description This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), comparative study to compare the efficacy of tramadol hydrochloride plus acetaminophen maintenance with that of NSAIDs maintenance in participants whose pain was relieved after the add-on treatment of tramadol 37.5 milligram (mg) plus acetaminophen 325 mg to NSAIDs. All participants will receive tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam [7.5 mg or 15 mg once daily] or aceclofenac [100 mg twice daily]) from Day 1 to Day 28, and participants will be randomly assigned into 2 treatment groups at Day 29 if the numerical rating scale score less than or equal 4. Tramadol plus acetaminophen group will receive 1 or 2 tablets containing tramadol 37.5 mg plus acetaminophen 325 mg 4 times daily (maximum daily dose will be 8 tablets) from Day 29 to Day 85 and NSAIDs group will receive either meloxicam 7.5 mg or 15 mg per day or aceclofenac 100 mg twice a day from Day 29 to Day 85. The efficacy will be evaluated on Day 1, Day 29, Day 57 and Day 85. The primary efficacy end point will be assessed through change in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score from Day 29 to Day 85. Participant's safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Meloxicam
    Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
  • Drug: Aceclofenac
    Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
  • Drug: Tramadol Hydrochloride Plus Acetaminophen
    Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam [7.5 mg or 15 mg once daily] or aceclofenac [100 mg twice daily]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).
Study Arms  ICMJE
  • Active Comparator: Non-steroidal Anti-inflammatory Drug (NSAIDs)
    Participants will receive fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numeric rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of NSAIDs to receive either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
    Interventions:
    • Drug: Meloxicam
    • Drug: Aceclofenac
    • Drug: Tramadol Hydrochloride Plus Acetaminophen
  • Experimental: Tramadol Hydrochloride Plus Acetaminophen
    Participants will receive fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numerical rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).
    Interventions:
    • Drug: Meloxicam
    • Drug: Aceclofenac
    • Drug: Tramadol Hydrochloride Plus 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: May 2, 2013)
143
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2008)
172
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants who have suffered from knee osteoarthritis at least for one year and meet the criteria of American College of Rheumatology
  • Participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily or aceclofenac 100 mg twice a day at least for four weeks
  • Participants whose mean pain intensity has been 5 or higher on the numeric rating scale (NRS) for the last 48 hours
  • Participants whose general health conditions are favorable, according to the criteria below: Medical and medication history, Physical examination before the study medication administration, Vital signs: Blood pressure, pulse, Clinical laboratory tests: Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) less-than or equal to (=<) 2 X normal range, Renal function: Creatinine less than (<) 2.0 milligrams per deciliter (mg/dl)
  • Female participants of childbearing potential to use the proper contraceptive methods during the study period (Urine pregnancy test prior to the study participation should be negative)

Exclusion Criteria:

  • Participants who are applicable to Kellgren and Lawrence grade
  • Participants who had failed tramadol treatment before or stopped taking tramadol due to adverse event(s)
  • Participants who are applicable to one of the following conditions: Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout, Diagnosis of fibromyalgia (according to ACR Criteria), Anserine bursitis, Major trauma of the target joint within six months prior to the study medication administration, Infection of the target joint within six months prior to the study medication administration, Apparent avascular necrosis of the target joint within six months prior to the study medication administration, Anatomical deformities of the target joint, which may interfere with assessment of the target joint, Surgical procedures associated with the target joint within one year prior to the study medication administration, Arthroscopic procedures associated with the target joint within six months prior to the study medication administration
  • Participants who have one of the following diseases: Significantly unstable diseases such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, Functional damage or disease which may cause malabsorption, excessive accumulation, or metabolism or excretion disorder
  • Participants who are pregnant or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 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 Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00635349
Other Study ID Numbers  ICMJE CR012964
ULT-KOR-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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 July 2013

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