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Trial record 8 of 10 for:    "Connective Tissue Disease" | "Diclofenac"

Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

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: NCT00264147
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : July 7, 2009
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: etoricoxib
Drug: Comparator: placebo
Drug: Comparator: diclofenac
Enrollment 761
Recruitment Details 90 multicenter rheumatologists: US (71), Canada (14), Colombia (3), Switzerland (2), recruited 761 study patients from their patient pool and through advertising. First Patient In 04-Jan-2006, Last Patient Last Visit 26-Mar-2008.
Pre-assignment Details Patients must have taken Non Steroidal Anti-inflammatory Drugs (NSAIDs) at a therapeutic labeled dose on a regular basis and demonstrated a clinical response in the past and at screening. Following a protocol-specified "washout," patients must have demonstrated disease activity and worsening in symptoms of Rheumatoid Arthritis from the screening.
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg Diclofenac 150 mg (Treatment II)
Hide Arm/Group Description Treatment I: Placebo orally once daily Treatment I: Etoricoxib 10 mg orally once daily Treatment I: Etoricoxib 30 mg orally once daily Treatment I: Etoricoxib 60 mg orally once daily Treatment I and II: Etoricoxib 90 mg orally once daily Treatment II: Diclofenac 75 mg orally twice daily
Period Title: Treatment I Period
Started 161 154 151 140 155 0
Completed 63 [1] 71 [1] 74 [1] 68 [1] 99 [1] 0
Not Completed 98 83 77 72 56 0
Reason Not Completed
Adverse Event             3             6             3             5             7             0
Laboratory Adverse Event             0             0             0             1             0             0
Lack of Efficacy             6             2             8             0             1             0
Lost to Follow-up             1             0             0             1             1             0
Protocol Violation             2             2             0             0             0             0
Withdrawal by Subject             2             0             0             2             2             0
Patient out of town for an extended time             0             1             0             0             0             0
Unblinded due to Serious Adverse Event             0             0             1             0             0             0
Reassigned to Treatment II Period             84             72             65             63             45             0
[1]
Randomized to Treatment I period and remained on Treatment I period during course of study
Period Title: Treatment II Period
Started 0 0 0 0 180 [1] 149 [2]
Completed 0 0 0 0 147 116
Not Completed 0 0 0 0 33 33
Reason Not Completed
Adverse Event             0             0             0             0             9             9
Laboratory Adverse Event             0             0             0             0             0             1
Lack of Efficacy             0             0             0             0             20             19
Lost to Follow-up             0             0             0             0             1             1
Withdrawal by Subject             0             0             0             0             3             2
Pre-scheduled total hip replacement             0             0             0             0             0             1
[1]
Etoricoxib 10 mg (38), 30 mg (28), 60 mg (33), 90 mg (45) and placebo (36) reassigned to 90 mg (180)
[2]
Etoricoxib 10 mg (34), 30 mg (37), 60 mg (29), and placebo (49) reassigned to diclofenac (149)
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg Total
Hide Arm/Group Description Treatment I: Placebo orally once daily Treatment I: Etoricoxib 10 mg orally once daily Treatment I: Etoricoxib 30 mg orally once daily Treatment I: Etoricoxib 60 mg orally once daily Treatment I: Etoricoxib 90 mg orally once daily Total of all reporting groups
Overall Number of Baseline Participants 161 154 151 140 155 761
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
57.4  (11.80) 58.7  (11.92) 56.2  (11.17) 57.7  (10.96) 54.9  (12.54) 57.0  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Female
136
  84.5%
117
  76.0%
126
  83.4%
112
  80.0%
122
  78.7%
613
  80.6%
Male
25
  15.5%
37
  24.0%
25
  16.6%
28
  20.0%
33
  21.3%
148
  19.4%
American Rheumatism Association Functional Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Class I 44 49 49 41 38 221
Class II 102 83 83 73 98 439
Class III 15 22 19 26 19 101
[1]
Measure Description: Class I: Completely able to perform usual activities of daily living (self care, vocational, and avocational), Class II: Able to perform usual self-care and vocational activities, but limited in avocational activities, Class III: Able to perform usual self-care activities, but limited in vocational and avocational activities
Corticosteroid User  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Yes 50 50 42 41 49 232
No 111 104 109 99 106 529
Disease Modifying Antirheumatic Drug User  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Yes 133 129 122 114 131 629
No 28 25 29 26 24 132
Disease Modifying Antirheumatic Drug or Corticosteroid User  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Yes 139 134 126 119 136 654
No 22 20 25 21 19 107
Methotrexate User  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Yes 99 91 96 93 93 472
No 62 63 55 47 62 289
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Asian 1 0 1 1 1 4
Black 5 8 3 7 6 29
White 114 106 121 96 112 549
Hispanic 41 39 25 34 36 175
Native American 0 0 1 2 0 3
Indian 0 1 0 0 0 1
Rheumatoid Factor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Positive 120 117 121 120 121 599
Negative 40 37 30 20 34 161
Not Reported 1 0 0 0 0 1
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
Current 27 28 29 23 22 129
Ex-User 53 46 42 39 40 220
Non-User 81 80 80 78 93 412
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
76.42  (16.54) 76.12  (18.48) 77.36  (20.00) 75.72  (19.54) 77.97  (18.61) 76.73  (18.58)
Duration of Rheumatoid Arthritis (Years)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
10.0  (9.78) 10.1  (9.76) 11.2  (8.40) 10.3  (10.18) 9.9  (9.98) 10.3  (9.62)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
161.93  (9.71) 163.63  (8.55) 164.57  (9.13) 162.96  (9.22) 163.49  (10.04) 163.30  (9.37)
Investigator Global Assessment of Disease Activity (0 to 4 - Likert Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
2.71  (0.61) 2.71  (0.67) 2.75  (0.66) 2.69  (0.63) 2.73  (0.65) 2.72  (0.64)
[1]
Measure Description: (0 to 4 - Likert Scale) 0=Very Well, 1=Well, 2=Fair, 3=Poor, 4=Very Poor
Patient Global Assessment of Disease Activity (0-To- 100 Millimeter Visual Analog Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
66.08  (18.67) 69.28  (19.37) 66.56  (20.47) 66.60  (19.58) 65.42  (18.45) 66.79  (19.30)
[1]
Measure Description: (0- to 100-mm Visual Analog Scale) 0 mm= No pain, 100 mm= Extreme pain
Patient Global Assessment of Pain (0- To- 100-mm Visual Analog Scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
72.66  (16.03) 72.42  (17.32) 70.95  (16.67) 69.54  (18.24) 71.08  (17.55) 71.38  (17.14)
[1]
Measure Description: (0- to 100-mm Visual Analog Scale) 0 mm= No pain, 100 mm= Extreme pain
Swollen Joint Count (Out of 66 Joints)  
Mean (Standard Deviation)
Unit of measure:  Number of Swollen Joints
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
16.05  (9.79) 17.75  (10.86) 16.74  (10.11) 15.79  (9.40) 16.30  (10.05) 16.53  (10.06)
Tender Joint Count (Out of 68 Joints)  
Mean (Standard Deviation)
Unit of measure:  Number of Tender Joints
Number Analyzed 161 participants 154 participants 151 participants 140 participants 155 participants 761 participants
26.91  (14.17) 28.33  (15.42) 27.19  (14.97) 26.76  (14.37) 27.25  (16.11) 27.30  (15.00)
1.Primary Outcome
Title Proportion of Patients Who Met the ACR20 Responder Index Criteria
Hide Description Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All-Patients-Treated Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 161 154 151 140 155
Measure Type: Number
Unit of Measure: Proportion of Patients
28.57 35.06 37.75 38.57 47.10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method Cochran-Armitage trend test
Comments A step-down procedure and Abelson-Tukey scaling were used for the trend test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method Cochran-Armitage trend test
Comments A step-down procedure and Abelson-Tukey scaling were used for the trend test.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage of patients
Estimated Value 18.53
Confidence Interval 95%
7.84 to 28.65
Estimation Comments CI based on the Wilson's score method.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage of patients
Estimated Value 10.00
Confidence Interval 95%
-0.66 to 20.46
Estimation Comments CI based on the Wilson's score method.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage of patients
Estimated Value 9.18
Confidence Interval 95%
-1.25 to 19.39
Estimation Comments CI based on the Wilson's score method.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage of patients
Estimated Value 6.49
Confidence Interval 95%
-3.76 to 16.61
Estimation Comments CI based on the Wilson's score method.
2.Secondary Outcome
Title Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Hide Description [Not Specified]
Time Frame Time-weighted average change from baseline across Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-Patients-Treatment Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 157 148 146 138 148
Mean (Standard Deviation)
Unit of Measure: Tender Joint Count
-8.13  (9.55) -11.01  (13.07) -10.96  (11.00) -9.56  (11.85) -12.06  (11.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.06
Confidence Interval 95%
-6.44 to -1.68
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.49
Confidence Interval 95%
-3.91 to 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.74
Confidence Interval 95%
-5.13 to -0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.50
Confidence Interval 95%
-4.88 to -0.12
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Hide Description [Not Specified]
Time Frame Time-weighted average change from baseline across Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-Patients-Treatment Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 157 148 146 138 148
Mean (Standard Deviation)
Unit of Measure: Swollen Joint Count
-5.39  (7.34) -6.58  (8.11) -6.91  (7.27) -6.25  (7.48) -7.77  (7.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.24
Confidence Interval 95%
-3.64 to -0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.02
Confidence Interval 95%
-2.44 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.22
Confidence Interval 95%
-2.63 to 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval 95%
-1.89 to 0.91
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Hide Description 0-mm indicates very well, 100-mm indicates very poor.
Time Frame Time-weighted average change from baseline across Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients-Treated Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 155 144 141 134 144
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-12.32  (25.66) -19.90  (23.61) -21.12  (24.47) -21.49  (26.71) -25.75  (25.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.16
Confidence Interval 95%
-19.38 to -8.95
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.21
Confidence Interval 95%
-14.52 to -3.90
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.87
Confidence Interval 95%
-14.11 to -3.63
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.05
Confidence Interval 95%
-11.27 to -0.83
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Hide Description 0 indicates very well, 4 indicates very poor.
Time Frame Time-weighted average change from baseline across Weeks 2, 7, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-Patients-Treatment Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 157 148 146 138 148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.68  (1.06) -0.93  (0.94) -1.09  (1.01) -1.01  (0.94) -1.24  (0.94)
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval 95%
-0.77 to -0.35
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval 95%
-0.55 to -0.13
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.40
Confidence Interval 95%
-0.61 to -0.19
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval 95%
-0.46 to -0.04
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Hide Description 0-mm indicates very well, 100-mm indicates very poor.
Time Frame Time-weighted average change from baseline across Weeks 2, 7, and 12
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All-Patients-Treated Population
Arm/Group Title Placebo Etoricoxib 10 mg Etoricoxib 30 mg Etoricoxib 60 mg Etoricoxib 90 mg
Hide Arm/Group Description:
Treatment I: Placebo orally once daily
Treatment I: Etoricoxib 10 mg orally once daily
Treatment I: Etoricoxib 30 mg orally once daily
Treatment I: Etoricoxib 60 mg orally once daily
Treatment I: Etoricoxib 90 mg orally once daily
Overall Number of Participants Analyzed 157 148 146 137 148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-17.44  (23.42) -21.95  (22.87) -22.75  (23.86) -22.25  (26.58) -31.07  (24.18)
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).
Method ANCOVA
Comments Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.44
Confidence Interval 95%
-19.62 to -9.26
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.22
Confidence Interval 95%
-11.52 to -0.92
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.32
Confidence Interval 95%
-11.53 to -1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.63
Confidence Interval 95%
-9.81 to 0.55
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Treatment I Period Etoricoxib 10 mg Treatment I Period Etoricoxib 30 mg Treatment I Period Etoricoxib 60 mg Treatment I Period Etoricoxib 90 mg Treatment I Period Etoricoxib 90 mg Treatment II Period Diclofenac 150 mg Treatment II Period
Hide Arm/Group Description Treatment I: Placebo orally once daily Treatment I: Etoricoxib 10 mg orally once daily Treatment I: Etoricoxib 30 mg orally once daily Treatment I: Etoricoxib 60 mg orally once daily Treatment I: Etoricoxib 90 mg orally once daily Treatment II: Etoricoxib 90 mg orally once daily Treatment II: Diclofenac 75 mg orally twice daily
All-Cause Mortality
Placebo Treatment I Period Etoricoxib 10 mg Treatment I Period Etoricoxib 30 mg Treatment I Period Etoricoxib 60 mg Treatment I Period Etoricoxib 90 mg Treatment I Period Etoricoxib 90 mg Treatment II Period Diclofenac 150 mg Treatment II Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treatment I Period Etoricoxib 10 mg Treatment I Period Etoricoxib 30 mg Treatment I Period Etoricoxib 60 mg Treatment I Period Etoricoxib 90 mg Treatment I Period Etoricoxib 90 mg Treatment II Period Diclofenac 150 mg Treatment II Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0   1   4   1   5   3   3 
Cardiac disorders               
Coronary Artery Disease * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Myocardial Infarction * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Gastrointestinal disorders               
Gastritis * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Ileus Paralytic * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Small Intestinal Obstruction * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  0/149 (0.00%) 
Infections and infestations               
Cellulitis * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  0/149 (0.00%) 
Erysipelas * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Injury, poisoning and procedural complications               
Accidental Overdose * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  1/149 (0.67%) 
Dislocation Of Joint Prosthesis * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  0/149 (0.00%) 
Femoral Neck Fracture * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  1/180 (0.56%)  0/149 (0.00%) 
Heat Exhaustion * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  0/149 (0.00%) 
Investigations               
Blood Creatinine Increased * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  1/140 (0.71%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Musculoskeletal and connective tissue disorders               
Intervertebral Disc Disorder * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Malignant Melanoma In Situ * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  1/149 (0.67%) 
Psychiatric disorders               
Depression * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  0/149 (0.00%) 
Obsessive-Compulsive Disorder * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  1/149 (0.67%) 
Reproductive system and breast disorders               
Ovarian Cyst * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  1/180 (0.56%)  0/149 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Haemothorax * 1  0/161 (0.00%)  0/154 (0.00%)  1/151 (0.66%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
Skin and subcutaneous tissue disorders               
Dermatitis * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  1/180 (0.56%)  0/149 (0.00%) 
Vascular disorders               
Hypertension * 1  0/161 (0.00%)  1/154 (0.65%)  0/151 (0.00%)  0/140 (0.00%)  0/155 (0.00%)  0/180 (0.00%)  0/149 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Treatment I Period Etoricoxib 10 mg Treatment I Period Etoricoxib 30 mg Treatment I Period Etoricoxib 60 mg Treatment I Period Etoricoxib 90 mg Treatment I Period Etoricoxib 90 mg Treatment II Period Diclofenac 150 mg Treatment II Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28   19   29   37   39   25   30 
Gastrointestinal disorders               
Abdominal Pain * 1  0/161 (0.00%)  0/154 (0.00%)  0/151 (0.00%)  0/140 (0.00%)  1/155 (0.65%)  0/180 (0.00%)  3/149 (2.01%) 
Abdominal Pain Upper * 1  2/161 (1.24%)  1/154 (0.65%)  1/151 (0.66%)  3/140 (2.14%)  2/155 (1.29%)  0/180 (0.00%)  2/149 (1.34%) 
Constipation * 1  0/161 (0.00%)  1/154 (0.65%)  5/151 (3.31%)  3/140 (2.14%)  2/155 (1.29%)  1/180 (0.56%)  1/149 (0.67%) 
Diarrhoea * 1  3/161 (1.86%)  4/154 (2.60%)  2/151 (1.32%)  8/140 (5.71%)  7/155 (4.52%)  4/180 (2.22%)  6/149 (4.03%) 
Dyspepsia * 1  5/161 (3.11%)  2/154 (1.30%)  1/151 (0.66%)  3/140 (2.14%)  6/155 (3.87%)  2/180 (1.11%)  4/149 (2.68%) 
Nausea * 1  2/161 (1.24%)  2/154 (1.30%)  2/151 (1.32%)  3/140 (2.14%)  3/155 (1.94%)  0/180 (0.00%)  2/149 (1.34%) 
General disorders               
Oedema Peripheral * 1  1/161 (0.62%)  2/154 (1.30%)  2/151 (1.32%)  5/140 (3.57%)  1/155 (0.65%)  6/180 (3.33%)  4/149 (2.68%) 
Infections and infestations               
Nasopharyngitis * 1  1/161 (0.62%)  4/154 (2.60%)  0/151 (0.00%)  1/140 (0.71%)  4/155 (2.58%)  2/180 (1.11%)  1/149 (0.67%) 
Sinusitis * 1  3/161 (1.86%)  1/154 (0.65%)  0/151 (0.00%)  1/140 (0.71%)  4/155 (2.58%)  2/180 (1.11%)  1/149 (0.67%) 
Upper Respiratory Tract Infection * 1  4/161 (2.48%)  0/154 (0.00%)  4/151 (2.65%)  1/140 (0.71%)  2/155 (1.29%)  4/180 (2.22%)  7/149 (4.70%) 
Urinary Tract Infection * 1  1/161 (0.62%)  1/154 (0.65%)  3/151 (1.99%)  0/140 (0.00%)  0/155 (0.00%)  2/180 (1.11%)  1/149 (0.67%) 
Musculoskeletal and connective tissue disorders               
Rheumatoid Arthritis * 1  3/161 (1.86%)  1/154 (0.65%)  3/151 (1.99%)  4/140 (2.86%)  2/155 (1.29%)  1/180 (0.56%)  3/149 (2.01%) 
Nervous system disorders               
Dizziness * 1  1/161 (0.62%)  1/154 (0.65%)  2/151 (1.32%)  4/140 (2.86%)  6/155 (3.87%)  0/180 (0.00%)  1/149 (0.67%) 
Headache * 1  6/161 (3.73%)  4/154 (2.60%)  5/151 (3.31%)  8/140 (5.71%)  5/155 (3.23%)  2/180 (1.11%)  0/149 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1  1/161 (0.62%)  1/154 (0.65%)  0/151 (0.00%)  3/140 (2.14%)  2/155 (1.29%)  0/180 (0.00%)  1/149 (0.67%) 
Vascular disorders               
Hypertension  1  0/161 (0.00%)  2/154 (1.30%)  3/151 (1.99%)  6/140 (4.29%)  5/155 (3.23%)  6/180 (3.33%)  1/149 (0.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00264147     History of Changes
Other Study ID Numbers: 0663-086
2005_077
First Submitted: December 9, 2005
First Posted: December 12, 2005
Results First Submitted: March 19, 2009
Results First Posted: July 7, 2009
Last Update Posted: February 16, 2015