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A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(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: NCT00491764
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : January 28, 2010
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Onychomycosis
Interventions Drug: SCH 56592
Drug: Terbinafine
Drug: Placebo
Enrollment 218
Recruitment Details  
Pre-assignment Details A total of 690 subjects were enrolled in the study and screened for eligibility. A total of 472 were screen-failures, leaving 218 subjects randomized to treatment.
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks. Posaconazole 400 mg QD for 24 Weeks. Posaconazole 400 mg QD for 12 Weeks. Terbinafine 250 mg QD for 12 Weeks. Placebo for 24 Weeks
Hide Arm/Group Description Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks. Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. Terbinafine 250 mg QD for 12 weeks. Placebo for 24 weeks.
Period Title: Overall Study
Started 37 37 36 36 36 36
Completed 32 30 28 28 33 27
Not Completed 5 7 8 8 3 9
Reason Not Completed
Adverse Event             1             2             4             4             0             1
Lost to Follow-up             0             1             0             1             0             3
Withdrawal by Subject             2             3             1             2             2             4
Non Compliance with the Protocol             1             0             0             0             0             0
Did not Meet Protocol Eligibility             0             1             1             0             1             1
Administrative             1             0             2             1             0             0
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks. Posaconazole 400 mg QD for 24 Weeks. Posaconazole 400 mg QD for 12 Weeks. Terbinafine 250 mg QD for 12 Weeks. Placebo for 24 Weeks Total
Hide Arm/Group Description Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks. Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks. Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks. Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks. Terbinafine 250 mg QD for 12 weeks. Placebo for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 37 37 36 36 36 36 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 36 participants 36 participants 36 participants 36 participants 218 participants
49.0  (13.0) 53.6  (10.8) 49.9  (13.2) 53.5  (11.8) 50.1  (12.2) 48.4  (14.8) 50.8  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 36 participants 36 participants 36 participants 36 participants 218 participants
Female
10
  27.0%
6
  16.2%
8
  22.2%
7
  19.4%
7
  19.4%
7
  19.4%
45
  20.6%
Male
27
  73.0%
31
  83.8%
28
  77.8%
29
  80.6%
29
  80.6%
29
  80.6%
173
  79.4%
1.Primary Outcome
Title Complete Cure of Onychomycosis at Week 48.
Hide Description Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).
Time Frame Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks. Posaconazole 400 mg QD for 24 Weeks. Posaconazole 400 mg QD for 12 Weeks. Terbinafine 250 mg QD for 12 Weeks. Placebo for 24 Weeks
Hide Arm/Group Description:
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine 250 mg QD for 12 weeks.
Placebo for 24 weeks.
Overall Number of Participants Analyzed 35 37 33 35 35 32
Measure Type: Number
Unit of Measure: Participants
8 20 15 7 13 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Posaconazole 100 mg QD for 24 Weeks, Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 22.9
Confidence Interval 95%
8.9 to 36.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Posaconazole 200 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 54.1
Confidence Interval 95%
38.0 to 70.1
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 45.5
Confidence Interval 95%
28.5 to 62.4
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 20.0
Confidence Interval 95%
6.7 to 33.3
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Terbinafine 250 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 37.1
Confidence Interval 95%
21.1 to 53.2
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
2.Secondary Outcome
Title Effective Treatment of Onychomycosis at Week 48.
Hide Description Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail
Time Frame Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks. Posaconazole 400 mg QD for 24 Weeks. Posaconazole 400 mg QD for 12 Weeks. Terbinafine 250 mg QD for 12 Weeks. Placebo for 24 Weeks
Hide Arm/Group Description:
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine 250 mg QD for 12 weeks.
Placebo for 24 weeks.
Overall Number of Participants Analyzed 35 37 33 35 35 32
Measure Type: Number
Unit of Measure: Participants
9 24 16 11 19 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Posaconazole 100 mg QD for 24 Weeks, Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 25.7
Confidence Interval 95%
11.2 to 40.2
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Posaconazole 200 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 64.9
Confidence Interval 95%
49.5 to 80.2
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 48.5
Confidence Interval 95%
31.4 to 65.5
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.4
Confidence Interval 95%
16.0 to 46.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Terbinafine 250 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 54.3
Confidence Interval 95%
37.8 to 70.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
3.Secondary Outcome
Title Treatment Success of Onychomycosis at Week 48
Hide Description Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.
Time Frame Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks. Posaconazole 400 mg QD for 24 Weeks. Posaconazole 400 mg QD for 12 Weeks. Terbinafine 250 mg QD for 12 Weeks. Placebo for 24 Weeks
Hide Arm/Group Description:
Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
Terbinafine 250 mg QD for 12 weeks.
Placebo for 24 weeks.
Overall Number of Participants Analyzed 35 37 33 35 35 32
Measure Type: Number
Unit of Measure: Participants
11 24 22 11 20 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Posaconazole 100 mg QD for 24 Weeks, Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.4
Confidence Interval 95%
16.0 to 46.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Posaconazole 200 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 64.9
Confidence Interval 95%
49.5 to 80.2
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 24 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 66.7
Confidence Interval 95%
50.6 to 82.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Posaconazole 400 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.4
Confidence Interval 95%
16.0 to 46.8
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Terbinafine 250 mg QD for 12 Weeks., Placebo for 24 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 57.1
Confidence Interval 95%
40.7 to 73.5
Estimation Comments Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.
Time Frame [Not Specified]
Adverse Event Reporting Description Number of participants at risk included the 216 subjects who received treatment. Of the 218 subjects randomized, 1 subject in the posaconazole 100 mg and 1 subject in the placebo group were not treated.
 
Arm/Group Title Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks Posaconazole 400 mg QD for 24 Weeks Posaconazole 400 mg QD for 12 Weeks Terbinafine 250 mg QD for 12 Weeks Placebo for 24 Weeks
Hide Arm/Group Description Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks Terbinafine 250 mg QD for 12 weeks Placebo for 24 weeks
All-Cause Mortality
Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks Posaconazole 400 mg QD for 24 Weeks Posaconazole 400 mg QD for 12 Weeks Terbinafine 250 mg QD for 12 Weeks Placebo for 24 Weeks
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
Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks Posaconazole 400 mg QD for 24 Weeks Posaconazole 400 mg QD for 12 Weeks Terbinafine 250 mg QD for 12 Weeks Placebo for 24 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/36 (2.78%)      1/37 (2.70%)      1/36 (2.78%)      1/36 (2.78%)      0/36 (0.00%)      3/35 (8.57%)    
Cardiac disorders             
ATRIAL FIBRILLATION  1  1/36 (2.78%)  1 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
MYOCARDIAL INFARCTION  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/35 (2.86%)  1
Gastrointestinal disorders             
UMBILICAL HERNIA  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/35 (2.86%)  1
General disorders             
NON-CARDIAC CHEST PAIN  1  0/36 (0.00%)  0 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations             
ABSCESS LIMB  1  0/36 (0.00%)  0 0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
APPENDICITIS  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/35 (2.86%)  1
CELLULITIS  1  0/36 (0.00%)  0 0/37 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/35 (2.86%)  1
Metabolism and nutrition disorders             
DEHYDRATION  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Posaconazole 100 mg QD for 24 Weeks Posaconazole 200 mg QD for 24 Weeks Posaconazole 400 mg QD for 24 Weeks Posaconazole 400 mg QD for 12 Weeks Terbinafine 250 mg QD for 12 Weeks Placebo for 24 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/36 (72.22%)      21/37 (56.76%)      20/36 (55.56%)      18/36 (50.00%)      20/36 (55.56%)      21/35 (60.00%)    
Cardiac disorders             
VENTRICULAR EXTRASYSTOLES  1  2/36 (5.56%)  2 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders             
DIARRHOEA  1  0/36 (0.00%)  0 2/37 (5.41%)  2 1/36 (2.78%)  1 4/36 (11.11%)  7 1/36 (2.78%)  1 2/35 (5.71%)  2
DYSPEPSIA  1  2/36 (5.56%)  2 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/35 (2.86%)  1
FLATULENCE  1  1/36 (2.78%)  1 1/37 (2.70%)  1 0/36 (0.00%)  0 2/36 (5.56%)  2 0/36 (0.00%)  0 0/35 (0.00%)  0
HYPERCHLORHYDRIA  1  1/36 (2.78%)  1 0/37 (0.00%)  0 0/36 (0.00%)  0 2/36 (5.56%)  2 0/36 (0.00%)  0 0/35 (0.00%)  0
NAUSEA  1  1/36 (2.78%)  1 3/37 (8.11%)  3 2/36 (5.56%)  6 0/36 (0.00%)  0 1/36 (2.78%)  1 2/35 (5.71%)  2
VOMITING  1  1/36 (2.78%)  6 2/37 (5.41%)  2 1/36 (2.78%)  4 0/36 (0.00%)  0 1/36 (2.78%)  2 0/35 (0.00%)  0
General disorders             
FATIGUE  1  3/36 (8.33%)  3 1/37 (2.70%)  1 1/36 (2.78%)  2 0/36 (0.00%)  0 2/36 (5.56%)  2 1/35 (2.86%)  1
PAIN  1  3/36 (8.33%)  3 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 2/35 (5.71%)  2
Immune system disorders             
SEASONAL ALLERGY  1  2/36 (5.56%)  6 1/37 (2.70%)  1 1/36 (2.78%)  1 1/36 (2.78%)  1 0/36 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations             
BRONCHITIS  1  0/36 (0.00%)  0 2/37 (5.41%)  2 1/36 (2.78%)  1 0/36 (0.00%)  0 2/36 (5.56%)  2 1/35 (2.86%)  1
GASTROENTERITIS VIRAL  1  3/36 (8.33%)  3 1/37 (2.70%)  1 0/36 (0.00%)  0 1/36 (2.78%)  1 1/36 (2.78%)  1 2/35 (5.71%)  2
INFLUENZA  1  3/36 (8.33%)  3 1/37 (2.70%)  1 2/36 (5.56%)  2 0/36 (0.00%)  0 3/36 (8.33%)  3 0/35 (0.00%)  0
LARYNGITIS  1  2/36 (5.56%)  2 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
NASOPHARYNGITIS  1  4/36 (11.11%)  6 3/37 (8.11%)  3 6/36 (16.67%)  7 2/36 (5.56%)  4 3/36 (8.33%)  3 6/35 (17.14%)  6
SINUSITIS  1  2/36 (5.56%)  3 1/37 (2.70%)  1 0/36 (0.00%)  0 2/36 (5.56%)  2 0/36 (0.00%)  0 2/35 (5.71%)  2
TINEA PEDIS  1  0/36 (0.00%)  0 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 3/35 (8.57%)  3
UPPER RESPIRATORY TRACT INFECTION  1  5/36 (13.89%)  5 1/37 (2.70%)  1 3/36 (8.33%)  3 6/36 (16.67%)  7 5/36 (13.89%)  5 1/35 (2.86%)  1
Investigations             
ALANINE AMINOTRANSFERASE INCREASED  1  0/36 (0.00%)  0 1/37 (2.70%)  1 2/36 (5.56%)  3 1/36 (2.78%)  1 1/36 (2.78%)  1 0/35 (0.00%)  0
BLOOD GLUCOSE INCREASED  1  1/36 (2.78%)  1 1/37 (2.70%)  1 0/36 (0.00%)  0 2/36 (5.56%)  2 3/36 (8.33%)  3 0/35 (0.00%)  0
HEPATIC ENZYME INCREASED  1  1/36 (2.78%)  1 0/37 (0.00%)  0 2/36 (5.56%)  2 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  2/36 (5.56%)  2 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
MUSCULOSKELETAL PAIN  1  2/36 (5.56%)  2 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/35 (0.00%)  0
MYALGIA  1  1/36 (2.78%)  2 2/37 (5.41%)  2 0/36 (0.00%)  0 1/36 (2.78%)  1 0/36 (0.00%)  0 1/35 (2.86%)  1
PAIN IN EXTREMITY  1  2/36 (5.56%)  2 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
Nervous system disorders             
AGEUSIA  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 2/36 (5.56%)  2 0/35 (0.00%)  0
DIZZINESS  1  0/36 (0.00%)  0 5/37 (13.51%)  5 0/36 (0.00%)  0 1/36 (2.78%)  1 1/36 (2.78%)  2 0/35 (0.00%)  0
HEADACHE  1  4/36 (11.11%)  4 1/37 (2.70%)  1 1/36 (2.78%)  13 3/36 (8.33%)  3 3/36 (8.33%)  3 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
COUGH  1  3/36 (8.33%)  4 1/37 (2.70%)  1 0/36 (0.00%)  0 0/36 (0.00%)  0 1/36 (2.78%)  1 0/35 (0.00%)  0
RESPIRATORY TRACT CONGESTION  1  1/36 (2.78%)  1 0/37 (0.00%)  0 0/36 (0.00%)  0 3/36 (8.33%)  3 0/36 (0.00%)  0 0/35 (0.00%)  0
SINUS CONGESTION  1  2/36 (5.56%)  3 2/37 (5.41%)  2 0/36 (0.00%)  0 4/36 (11.11%)  5 2/36 (5.56%)  3 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders             
INGROWING NAIL  1  2/36 (5.56%)  2 0/37 (0.00%)  0 4/36 (11.11%)  5 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
ONYCHALGIA  1  2/36 (5.56%)  2 0/37 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/36 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders             
HYPERTENSION  1  0/36 (0.00%)  0 0/37 (0.00%)  0 0/36 (0.00%)  0 2/36 (5.56%)  2 1/36 (2.78%)  1 0/35 (0.00%)  0
Indicates events were collected by 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.
PI must provide to sponsor 45 days prior to submission for publication/presentation, review copies of content to be presented that contains any results of the study. The sponsor has the right to review/comment with regard to proprietary information, accuracy, and fair balance. If disagreements arise concerning appropriateness of content to be presented, investigator must meet with sponsor prior to submission for publication to make good faith efforts to discuss/resolve any issues/disagreement.
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: NCT00491764     History of Changes
Other Study ID Numbers: P05082
First Submitted: June 25, 2007
First Posted: June 26, 2007
Results First Submitted: December 23, 2009
Results First Posted: January 28, 2010
Last Update Posted: April 7, 2017