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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Meloxicam
Drug: Aceclofenac
Drug: Tramadol Hydrochloride Plus Acetaminophen
Enrollment 143
Recruitment Details  
Pre-assignment Details A total of 143 participants were given informed consent, out of which 3 participants had screening failure.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85. Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Period Title: Overall Study
Started 73 67
Completed 29 19
Not Completed 44 48
Reason Not Completed
Other             8             6
Protocol Violation             18             22
Withdrawal by Subject             3             8
Lost to Follow-up             4             3
Adverse Event             11             9
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen Total
Hide Arm/Group Description Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85. Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets). Total of all reporting groups
Overall Number of Baseline Participants 73 67 140
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 67 participants 140 participants
60.0  (8.0) 62.3  (7.6) 61.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 67 participants 140 participants
Female
62
  84.9%
56
  83.6%
118
  84.3%
Male
11
  15.1%
11
  16.4%
22
  15.7%
1.Primary Outcome
Title Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
Hide Description 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.
Time Frame Day 29 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 29 33.54  (15.01) 39.44  (14.17)
Change at Day 85 -1.88  (11.07) -0.07  (13.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-steroidal Anti-inflammatory Drugs (NSAIDs), Tramadol Hydrochloride Plus Acetaminophen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)
Statistical Test of Hypothesis P-Value 0.4258
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.81
Confidence Interval (1-Sided) 97.5%
-6.31
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Day 29 in Pain Intensity Score at Day 85
Hide Description 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.
Time Frame Day 29 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 56 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 29 3.82  (1.22) 3.81  (1.03)
Change at Day 85 0.14  (1.76) 0.83  (2.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-steroidal Anti-inflammatory Drugs (NSAIDs), Tramadol Hydrochloride Plus Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0628
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (1-Sided) 97.5%
-1.41
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Pain Relief
Hide Description 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.
Time Frame Day 29, Day 57 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: participants
Day 29; Pain relieved (n=56, 52) 49 42
Day 57; Pain relieved (n=47, 41) 32 28
Day 85; Pain relieved (n=55, 56) 42 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-steroidal Anti-inflammatory Drugs (NSAIDs), Tramadol Hydrochloride Plus Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0131
Comments Day 29: p-value was calculated by fisher exact test
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-steroidal Anti-inflammatory Drugs (NSAIDs), Tramadol Hydrochloride Plus Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9834
Comments Day 57; p-value was calculated by Chi-squared test
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-steroidal Anti-inflammatory Drugs (NSAIDs), Tramadol Hydrochloride Plus Acetaminophen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1131
Comments Day 85; p-value was calculated by Chi-squared test
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Overall Assessment on Study Drug by Participants
Hide Description 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.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: participants
Very bad 1 1
Bad 2 11
Moderate 21 22
Good 29 21
Very good 4 2
5.Secondary Outcome
Title Number of Participants With Overall Assessment on Study Drug by Investigator
Hide Description 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.
Time Frame Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: participants
Very bad 1 0
Bad 1 6
Moderate 21 25
Good 31 24
Very good 3 2
6.Secondary Outcome
Title Number of Participants With Categorical Swelling
Hide Description 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).
Time Frame Day 29, Day 57 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: participants
Day 29; No swelling (n=56, 52) 52 45
Day 29; PCFF (n=56, 52) 4 7
Day 57; No swelling (n=47, 41) 43 38
Day 57; PCFF (n=47, 41) 4 3
Day 85; No swelling (n=55, 56) 53 46
Day 85; PCFF (n=55, 56) 1 9
Day 85; Patellar ballotment (n=55, 56) 1 1
7.Secondary Outcome
Title Number of Participants With Categorical Tenderness
Hide Description 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.
Time Frame Day 29, Day 57 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description:
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
Overall Number of Participants Analyzed 59 59
Measure Type: Number
Unit of Measure: participants
Day 29; No tenderness(n=56, 52) 33 37
Day 29; Complaint of tenderness (n=56, 52) 22 14
Day 29; CTW (n=56, 52) 0 1
Day 29; Wincing and attempt to withdraw (n=56, 52) 1 0
Day 57; No tenderness(n=47, 41) 33 30
Day 57; Complaint of tenderness (n=47, 41) 14 10
Day 57; CTW (n=47, 41) 0 1
Day 57; wincing and attempt to withdraw(n=47, 41) 0 0
Day 85; No tenderness(n=55, 56) 39 44
Day 85; Complaint of tenderness (n=55, 56) 15 10
Day 85; CTW (n=55, 56) 0 2
Day 85; Wincing and attempt to withdraw(n=55, 56) 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population included all participants who received at least 1 dose study drug and had safety data.
 
Arm/Group Title Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Hide Arm/Group Description Participants received 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 had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85. Participants received 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 had the numeric rating scale score 4 or less on Day 29 were 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 was 8 tablets).
All-Cause Mortality
Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   1/73 (1.37%)   0/67 (0.00%) 
Vascular disorders     
Thromboangiitis obliterans * 1  1/73 (1.37%)  0/67 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non-steroidal Anti-inflammatory Drugs (NSAIDs) Tramadol Hydrochloride Plus Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   17/73 (23.29%)   12/67 (17.91%) 
Gastrointestinal disorders     
Nausea * 1  7/73 (9.59%)  4/67 (5.97%) 
Constipation * 1  6/73 (8.22%)  5/67 (7.46%) 
Dyspepsia * 1  3/73 (4.11%)  4/67 (5.97%) 
Dizziness * 1  6/73 (8.22%)  5/67 (7.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V16.0
There was no wash-out period after Day 28 to show drug efficacy in participants whose pain was already relieved and results were not meet the objective by setting inappropriate non-inferiority limit by applying WOMAC total score in hypothesis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigator (PI) cannot provide any trial related information to external parties’ without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Director
Organization: Janssen Korea / 25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702 Korea
Phone: 82-2-2094-4518
Layout table for additonal information
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00635349     History of Changes
Other Study ID Numbers: CR012964
ULT-KOR-05
First Submitted: March 6, 2008
First Posted: March 13, 2008
Results First Submitted: May 2, 2013
Results First Posted: June 24, 2013
Last Update Posted: July 22, 2013