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Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Korean Participants With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01554163
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : December 4, 2013
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: Etoricoxib 30 mg
Drug: Celecoxib 200 mg
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description Etoricoxib 30 mg administered orally once daily for 12 weeks. Celecoxib 200 mg administered orally once daily for 12 weeks.
Period Title: Overall Study
Started 120 119
Number Treated 119 119
Completed 112 109
Not Completed 8 10
Reason Not Completed
Adverse Event             3             0
Lack of Efficacy             1             0
Lost to Follow-up             1             0
Non-Compliance With Study Drug             1             1
Protocol Violation             0             4
Withdrawal by Subject             1             5
Not Treated             1             0
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg Total
Hide Arm/Group Description Etoricoxib 30 mg administered orally once daily for 12 weeks. Celecoxib 200 mg administered orally once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 120 119 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 119 participants 239 participants
40 to 50 years 4 10 14
51 to 60 years 41 40 81
61 to 70 years 46 47 93
71 to 80 years 27 18 45
81 to 90 years 2 4 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 119 participants 239 participants
Female
110
  91.7%
104
  87.4%
214
  89.5%
Male
10
   8.3%
15
  12.6%
25
  10.5%
1.Primary Outcome
Title Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Hide Description The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Baseline, Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-21.40  (1.35) -19.76  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).
Statistical Test of Hypothesis P-Value 0.390
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.63
Confidence Interval (2-Sided) 95%
-5.37 to 2.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale
Hide Description The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Baseline, Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-17.78  (1.28) -16.46  (1.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.
Statistical Test of Hypothesis P-Value 0.464
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.32
Confidence Interval (2-Sided) 95%
-4.88 to 2.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status
Hide Description The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, “Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing.” The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Baseline, Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-24.71  (1.58) -23.61  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-5.48 to 3.30
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy
Hide Description Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
1.48  (0.06) 1.56  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.369
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.26 to 0.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status
Hide Description Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Baseline, Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.71  (0.06) -1.62  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.25 to 0.08
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale
Hide Description The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Baseline, Week 2, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-18.41  (1.48) -17.55  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-4.96 to 3.24
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy
Hide Description Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time Frame Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description:
Etoricoxib 30 mg administered orally once daily for 12 weeks.
Celecoxib 200 mg administered orally once daily for 12 weeks.
Overall Number of Participants Analyzed 119 119
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
1.39  (0.07) 1.49  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etoricoxib 30 mg, Celecoxib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.30 to 0.10
Estimation Comments [Not Specified]
Time Frame Up to 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etoricoxib 30 mg Celecoxib 200 mg
Hide Arm/Group Description Etoricoxib 30 mg administered orally once daily for 12 weeks. Celecoxib 200 mg administered orally once daily for 12 weeks.
All-Cause Mortality
Etoricoxib 30 mg Celecoxib 200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etoricoxib 30 mg Celecoxib 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/119 (0.00%)      1/119 (0.84%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid cancer  1  0/119 (0.00%)  0 1/119 (0.84%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etoricoxib 30 mg Celecoxib 200 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/119 (10.08%)      3/119 (2.52%)    
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/119 (10.08%)  20 3/119 (2.52%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01554163     History of Changes
Other Study ID Numbers: 0663-112
First Submitted: March 12, 2012
First Posted: March 14, 2012
Results First Submitted: September 25, 2013
Results First Posted: December 4, 2013
Last Update Posted: October 9, 2015