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A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)

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: NCT00694369
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : January 29, 2010
Last Update Posted : March 21, 2016
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 Postoperative Dental Pain
Interventions Drug: Comparator: etoricoxib
Drug: Comparator: ibuprofen
Drug: Comparator: acetaminophen + codeine
Drug: Comparator: placebo
Enrollment 588
Recruitment Details Study Conducted at 3 investigational sites in the US. Patients were recruited from the sites patient pool and through advertising. A total of 588 patients were randomized. First Patient Entered 27-June-2008; First Patient In (randomized) on 03-July- 2008; Last Patient Last Visit 08-Jan-09
Pre-assignment Details

Patients who met entry criteria and were experiencing moderate-to-severe pain after removal of at least 2

third molars (at least 1 being partially or completely impacted and of mandibular origin) were allocated to

the study. Wash-out period for exclusionary medication was specified in the protocol. Randomization was

stratified by baseline pain.

Arm/Group Title Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Hide Arm/Group Description Placebo orally once daily Etoricoxib 90 mg orally once daily Etoricoxib 120 mg orally once daily Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
Period Title: Overall Study
Started 46 191 97 192 62
Completed 45 188 95 189 56
Not Completed 1 3 2 3 6
Reason Not Completed
Adverse Event             0             1             0             1             3
Lost to Follow-up             0             0             1             1             0
Physician Decision             0             0             0             0             1
Protocol Violation             0             1             0             0             0
Withdrawal by Subject             1             1             1             1             2
Arm/Group Title Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg Total
Hide Arm/Group Description Placebo orally once daily Etoricoxib 90 mg orally once daily Etoricoxib 120 mg orally once daily Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally Total of all reporting groups
Overall Number of Baseline Participants 46 191 97 192 62 588
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
21.0  (3.0) 21.8  (3.6) 21.8  (3.5) 21.6  (3.8) 20.5  (2.8) 21.5  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
Female
25
  54.3%
113
  59.2%
50
  51.5%
115
  59.9%
37
  59.7%
340
  57.8%
Male
21
  45.7%
78
  40.8%
47
  48.5%
77
  40.1%
25
  40.3%
248
  42.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
Hispanic or Latino
11
  23.9%
52
  27.2%
25
  25.8%
50
  26.0%
17
  27.4%
155
  26.4%
Not Hispanic or Latino
35
  76.1%
139
  72.8%
72
  74.2%
142
  74.0%
44
  71.0%
432
  73.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
2
   2.1%
1
   0.5%
1
   1.6%
5
   0.9%
Asian
0
   0.0%
6
   3.1%
4
   4.1%
9
   4.7%
0
   0.0%
19
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.5%
1
   1.0%
1
   0.5%
1
   1.6%
4
   0.7%
Black or African American
2
   4.3%
4
   2.1%
1
   1.0%
7
   3.6%
3
   4.8%
17
   2.9%
White
43
  93.5%
174
  91.1%
86
  88.7%
173
  90.1%
56
  90.3%
532
  90.5%
More than one race
1
   2.2%
5
   2.6%
3
   3.1%
1
   0.5%
1
   1.6%
11
   1.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Pain Intensity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
Moderate 21 98 49 106 30 304
Severe 25 93 48 86 32 284
[1]
Measure Description:

The level of pain at baseline (before dosing) is indicated by the patient on the patient diary by placing a check mark next to the appropriate response to the following question (My starting pain is: None, Slight, Moderate, Severe). Patients who indicated moderate to severe pain at baseline were eligible to be

randomized into the study.

Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
71.21  (16.33) 72.53  (16.68) 71.02  (15.96) 72.24  (16.81) 69.43  (13.99) 71.76  (16.29)
Duration of Surgery  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
0.14  (0.06) 0.13  (0.06) 0.15  (0.08) 0.14  (0.06) 0.13  (0.06) 0.14  (0.06)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
171.03  (8.91) 168.39  (9.95) 167.92  (10.07) 168.50  (9.05) 168.38  (9.86) 168.56  (9.59)
Mean Impaction Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a Scale
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
2.41  (0.51) 2.44  (0.50) 2.40  (0.52) 2.50  (0.48) 2.40  (0.51) 2.45  (0.50)
[1]
Measure Description:

Impaction Score (Soft Tissue =1, Partial Embedded= 2,

Embedded = 3)

Number of Hours from End of Surgery to Dosing  
Mean (Standard Deviation)
Unit of measure:  Hours
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
3.06  (0.79) 2.94  (0.77) 2.84  (0.75) 3.01  (0.84) 2.97  (0.78) 2.96  (0.79)
Number of Teeth Removed  
Mean (Standard Deviation)
Unit of measure:  Teeth
Number Analyzed 46 participants 191 participants 97 participants 192 participants 62 participants 588 participants
2.04  (0.29) 2.06  (0.27) 2.10  (0.39) 2.02  (0.12) 2.03  (0.18) 2.05  (0.26)
1.Primary Outcome
Title Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
Hide Description TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
Time Frame Over the first 6 hours post the initial Day 1 dose of the study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.
Arm/Group Title Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Hide Arm/Group Description:
Placebo orally once daily
Etoricoxib 90 mg orally once daily
Etoricoxib 120 mg orally once daily
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
Overall Number of Participants Analyzed 46 191 97 192 62
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
5.08  (0.86) 16.10  (0.42) 15.73  (0.59) 15.67  (0.42) 11.83  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 120 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 0.05 critical level was used.
Method ANOVA
Comments

Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value

for 120-mg dose comparison is significant).

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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 0.05 critical level was used.
Method ANOVA
Comments Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etoricoxib 120 mg, Ibuprofen 2400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.06
Confidence Interval 95%
-1.37 to 1.48
Estimation Comments Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etoricoxib 90 mg, Ibuprofen 2400 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.43
Confidence Interval 95%
-0.73 to 1.60
Estimation Comments Difference in LS Means (etoricoxib minus ibuprofen)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etoricoxib 120 mg, Acetaminophen 2400 mg/Codeine 240 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 3.90
Confidence Interval 95%
2.04 to 5.76
Estimation Comments Difference in LS Means (etoricoxib minus acetaminophen/codeine)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Etoricoxib 90 mg, Acetaminophen 2400 mg/Codeine 240 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 4.27
Confidence Interval 95%
2.61 to 5.94
Estimation Comments Difference in LS Means (etoricoxib minus acetaminophen/codeine)
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etoricoxib 90 mg, Etoricoxib 120 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.38
Confidence Interval 95%
-1.80 to 1.05
Estimation Comments Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 2400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 10.59
Confidence Interval 95%
8.72 to 12.47
Estimation Comments Difference in LS Means (ibuprofen 2400 mg minus placebo)
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 2400 mg/Codeine 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 6.75
Confidence Interval 95%
4.53 to 8.97
Estimation Comments Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)
2.Secondary Outcome
Title Patient’s Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Hide Description Patient’s Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient’s rating of the study medication for pain.
Time Frame At 24 hours post the initial Day 1 dose of the study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.
Arm/Group Title Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Hide Arm/Group Description:
Placebo orally once daily
Etoricoxib 90 mg orally once daily
Etoricoxib 120 mg orally once daily
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
Overall Number of Participants Analyzed 44 184 86 180 54
Measure Type: Number
Unit of Measure: Participants
Poor 19 12 7 6 1
Fair 12 12 5 24 13
Good 5 43 20 42 15
Very Good 5 66 26 73 18
Excellent 3 51 28 35 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etoricoxib 120 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 0.05 critical level was used.
Method stratified Wilcoxon rank sum test
Comments Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 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 0.05 critical level was used.
Method stratified Wilcoxon rank sum test
Comments Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etoricoxib 120 mg, Ibuprofen 2400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments 0.05 critical level was used.
Method stratified Wilcoxon rank sum test
Comments Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Etoricoxib 120 mg, Acetaminophen 2400 mg/Codeine 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments 0.05 critical level was used.
Method stratified Wilcoxon rank sum test
Comments Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etoricoxib 90 mg, Acetaminophen 2400 mg/Codeine 240 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments 0.05 critical level was used.
Method stratified Wilcoxon rank sum test
Comments Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.
Time Frame Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Hide Arm/Group Description Placebo orally once daily Etoricoxib 90 mg orally once daily Etoricoxib 120 mg orally once daily Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
All-Cause Mortality
Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
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 Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/191 (0.00%)   0/97 (0.00%)   0/192 (0.00%)   0/62 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Etoricoxib 90 mg Etoricoxib 120 mg Ibuprofen 2400 mg Acetaminophen 2400 mg/Codeine 240 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/46 (26.09%)   54/191 (28.27%)   28/97 (28.87%)   57/192 (29.69%)   35/62 (56.45%) 
Blood and lymphatic system disorders           
Lymphadenopathy * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Cardiac disorders           
Palpitations * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Ear and labyrinth disorders           
Ear pain * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  2/192 (1.04%)  0/62 (0.00%) 
Eye disorders           
Blepharospasm * 1  1/46 (2.17%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Dry Eye * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Vision Blurred * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  2/192 (1.04%)  0/62 (0.00%) 
Visual Impairment * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders           
Abdominal pain upper * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Aphthous stomatitis * 1  0/46 (0.00%)  3/191 (1.57%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Constipation * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  3/192 (1.56%)  0/62 (0.00%) 
Diarrhoea * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  3/192 (1.56%)  0/62 (0.00%) 
Dyspepsia * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Flatulence * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Gingival pain * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Gingivitis * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Nausea * 1  3/46 (6.52%)  6/191 (3.14%)  4/97 (4.12%)  10/192 (5.21%)  23/62 (37.10%) 
Sensitivity of teeth * 1  0/46 (0.00%)  1/191 (0.52%)  1/97 (1.03%)  1/192 (0.52%)  0/62 (0.00%) 
Stomach discomfort * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Toothache * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Vomiting * 1  1/46 (2.17%)  2/191 (1.05%)  1/97 (1.03%)  2/192 (1.04%)  15/62 (24.19%) 
General disorders           
Asthenia * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Chills * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Facial pain * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Fatigue * 1  0/46 (0.00%)  3/191 (1.57%)  0/97 (0.00%)  1/192 (0.52%)  1/62 (1.61%) 
Feeling cold * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Feeling hot * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Influenza like illness * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Malaise * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Thirst * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Infections and infestations           
Alveolar osteitis * 1  0/46 (0.00%)  8/191 (4.19%)  3/97 (3.09%)  8/192 (4.17%)  1/62 (1.61%) 
Fungal infection * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Gastroenteritis viral * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Incision site infection * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Influenza * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Nasopharyngitis * 1  0/46 (0.00%)  0/191 (0.00%)  2/97 (2.06%)  0/192 (0.00%)  0/62 (0.00%) 
Oral herpes * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Oral infection * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Upper respiratory tract infection * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Urinary tract infection * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Vulvovaginal mycotic infection * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Injury, poisoning and procedural complications           
Accidental Overdose * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Incision site haemorrhage * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Post procedural haemorrhage * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Procedural site reaction * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Investigations           
Heart rate increased * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Metabolism and nutrition disorders           
Appetite disorder * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders           
Flank pain * 1  1/46 (2.17%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Musculoskeletal chest pain * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Neck Pain * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Pain in extremity * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Pain in jaw * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Nervous system disorders           
Dizziness * 1  2/46 (4.35%)  4/191 (2.09%)  0/97 (0.00%)  3/192 (1.56%)  10/62 (16.13%) 
Dysgeusia * 1  0/46 (0.00%)  2/191 (1.05%)  3/97 (3.09%)  0/192 (0.00%)  0/62 (0.00%) 
Headache * 1  6/46 (13.04%)  11/191 (5.76%)  5/97 (5.15%)  8/192 (4.17%)  9/62 (14.52%) 
Paraesthesia * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  1/62 (1.61%) 
Sinus headache * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Somnolence * 1  0/46 (0.00%)  4/191 (2.09%)  2/97 (2.06%)  6/192 (3.13%)  5/62 (8.06%) 
Syncope * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Tremor * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  1/62 (1.61%) 
Psychiatric disorders           
Affect lability * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Insomnia * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Nightmare * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Renal and urinary disorders           
Chromaturia * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Pollakiuria * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Reproductive system and breast disorders           
Erectile dysfunction * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Dry Throat * 1  1/46 (2.17%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Dyspnoea * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Epistaxis * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Nasal Congestion * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Oropharyngeal pain * 1  0/46 (0.00%)  2/191 (1.05%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Pharyngeal oedema * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Rhinorrhoea * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Sinus congestion * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Throat irritation * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Dry Skin * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  0/192 (0.00%)  0/62 (0.00%) 
Ecchymosis * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Hyperhidrosis * 1  1/46 (2.17%)  1/191 (0.52%)  1/97 (1.03%)  1/192 (0.52%)  2/62 (3.23%) 
Pruritis * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  1/62 (1.61%) 
Rash * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Rash generalized * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Rash pruritic * 1  0/46 (0.00%)  0/191 (0.00%)  1/97 (1.03%)  0/192 (0.00%)  0/62 (0.00%) 
Urticaria * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Vascular disorders           
Flushing * 1  2/46 (4.35%)  0/191 (0.00%)  1/97 (1.03%)  1/192 (0.52%)  0/62 (0.00%) 
Haematoma * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Hot flush * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
Hypertension * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Hypotension * 1  0/46 (0.00%)  0/191 (0.00%)  0/97 (0.00%)  0/192 (0.00%)  1/62 (1.61%) 
Pallor * 1  0/46 (0.00%)  1/191 (0.52%)  0/97 (0.00%)  1/192 (0.52%)  0/62 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
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
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
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00694369     History of Changes
Other Study ID Numbers: 0663-092
MK0663-092
2008_506
First Submitted: June 6, 2008
First Posted: June 10, 2008
Results First Submitted: November 13, 2009
Results First Posted: January 29, 2010
Last Update Posted: March 21, 2016