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MK3207 for Treatment of Acute Migraines (3207-005)

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: NCT00712725
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : November 22, 2010
Last Update Posted : February 2, 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 Migraine
Interventions Drug: MK3207- 2.5 mg
Drug: MK3207- 5 mg
Drug: MK3207- 10 mg
Drug: MK3207- 20 mg
Drug: MK3207- 50 mg
Drug: MK3207- 100 mg
Drug: Comparator: placebo (unspecified)
Enrollment 676
Recruitment Details Participants were recruited from 47 neurological and general research centers worldwide (19 in the United States and 28 internationally). The primary therapy period was between 2-Jul-08 to 16-Jan-09.
Pre-assignment Details Participants were assessed using the protocol inclusion and exclusion criteria at Visit 1 and, if eligible, were randomized at the same visit.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Period Title: Overall Study
Started 169 39 57 84 86 84 83 74
Completed 140 [1] 33 [1] 47 [1] 67 [1] 67 [1] 68 [1] 61 [2] 63 [1]
Not Completed 29 6 10 17 19 16 22 11
Reason Not Completed
Adverse Event             1             0             0             1             0             0             0             0
Lost to Follow-up             3             2             1             1             2             2             3             1
Physician Decision             2             0             0             0             1             0             2             0
Pregnancy             0             1             0             0             1             0             2             0
Protocol Violation             2             0             1             3             2             0             1             1
Withdrawal by Subject             2             1             1             2             1             1             1             2
Lack of Qualifying Event             16             2             6             8             11             13             11             6
Protocol Specified Criteria             3             0             1             2             1             0             2             1
[1]
The "Not Completed" patients discontinued prior to receiving study medication.
[2]
One patient received study drug. The remaining patients discontinued prior to receiving study drug.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg Total
Hide Arm/Group Description

Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

Total of all reporting groups
Overall Number of Baseline Participants 140 33 47 67 67 68 62 63 547
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 33 participants 47 participants 67 participants 67 participants 68 participants 62 participants 63 participants 547 participants
42.1  (11.2) 43.3  (10.5) 43.4  (11.1) 44.1  (10.0) 44.1  (11.3) 42.2  (10.8) 42.2  (10.9) 40.5  (10.7) 42.7  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 33 participants 47 participants 67 participants 67 participants 68 participants 62 participants 63 participants 547 participants
Female
125
  89.3%
27
  81.8%
40
  85.1%
62
  92.5%
54
  80.6%
62
  91.2%
52
  83.9%
54
  85.7%
476
  87.0%
Male
15
  10.7%
6
  18.2%
7
  14.9%
5
   7.5%
13
  19.4%
6
   8.8%
10
  16.1%
9
  14.3%
71
  13.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 33 participants 47 participants 67 participants 67 participants 68 participants 62 participants 63 participants 547 participants
Hispanic or Latino
15
  10.7%
4
  12.1%
4
   8.5%
4
   6.0%
10
  14.9%
13
  19.1%
9
  14.5%
10
  15.9%
69
  12.6%
Not Hispanic or Latino
125
  89.3%
29
  87.9%
43
  91.5%
63
  94.0%
57
  85.1%
55
  80.9%
53
  85.5%
53
  84.1%
478
  87.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 33 participants 47 participants 67 participants 67 participants 68 participants 62 participants 63 participants 547 participants
White 132 32 46 62 63 64 59 59 517
Black 5 0 1 3 1 2 2 3 17
Asian 1 1 0 0 1 1 1 1 6
American Indian or Alaska Native 1 0 0 1 1 0 0 0 3
Native Hawaiian or Other Pacific Islander 0 0 0 1 0 1 0 0 2
Multi-Racial 1 0 0 0 1 0 0 0 2
Study Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 33 participants 47 participants 67 participants 67 participants 68 participants 62 participants 63 participants 547 participants
United States 66 14 22 30 39 45 34 20 270
Ex-United States 74 19 25 37 28 23 28 43 277
1.Primary Outcome
Title Pain Freedom (PF)
Hide Description

Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.

Rating of Headache Severity (Scale from Grade 0 to 3):

  • Grade 0: No pain
  • Grade 1: Mild pain
  • Grade 2: Moderate pain
  • Grade 3: Severe pain
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 44 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
13 4 5 16 12 14 14 21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
2.Secondary Outcome
Title Pain Relief (PR)
Hide Description

Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.

Rating of Headache Severity (Scale from Grade 0 to 3):

  • Grade 0: No pain
  • Grade 1: Mild pain
  • Grade 2: Moderate pain
  • Grade 3: Severe pain
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 44 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
48 15 19 36 36 41 31 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
3.Secondary Outcome
Title Absence of Photophobia
Hide Description Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 44 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
51 10 15 32 27 32 26 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
4.Secondary Outcome
Title Absence of Phonophobia
Hide Description Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 44 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
57 12 18 35 35 38 31 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
5.Secondary Outcome
Title Absence of Nausea
Hide Description Absence of nausea at 2 hours postdose as recorded by patient on paper diary.
Time Frame 2 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 43 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
79 19 25 44 42 44 41 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
6.Secondary Outcome
Title Sustained Pain Freedom (SPF)
Hide Description Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.
Time Frame 2-24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description:
Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 133 32 44 63 63 65 59 58
Measure Type: Number
Unit of Measure: Participants
10 4 2 13 10 12 12 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK3207 2.5 mg, MK3207 5 mg, MK3207 10 mg, MK3207 20 mg, MK3207 50 mg, MK3207 100 mg, MK3207 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.
Method Generalized linear regression model
Comments Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.
Time Frame Patients were assessed for AEs from V1 (Pre-treatment Screening/Randomization) through 14 days after the dose of study medication was taken. AEs that occurred prior to administration of study medication were not included in AE summaries.
Adverse Event Reporting Description

Every patient is counted a single time for each applicable specific adverse event.

Patients in population are patients who took at least one tablet of the study medication.

Placebo is the pooled arm of all matching placebo doses.

 
Arm/Group Title Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Hide Arm/Group Description Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache. MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
All-Cause Mortality
Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Affected / at Risk (%) 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 MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/142 (0.70%)   0/32 (0.00%)   0/47 (0.00%)   1/66 (1.52%)   0/67 (0.00%)   0/68 (0.00%)   0/62 (0.00%)   0/63 (0.00%) 
Cardiac disorders                 
Cardiac failure congestive * 1  1/142 (0.70%)  0/32 (0.00%)  0/47 (0.00%)  0/0  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Immune system disorders                 
Hypersensitivity * 1  1/142 (0.70%)  0/32 (0.00%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Ovarian cyst * 1  0/142 (0.00%)  0/32 (0.00%)  0/47 (0.00%)  1/66 (1.52%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
*
Indicates events were collected by non-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 2%
Placebo MK3207 2.5 mg MK3207 5 mg MK3207 10 mg MK3207 20 mg MK3207 50 mg MK3207 100 mg MK3207 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/142 (14.08%)   10/32 (31.25%)   18/47 (38.30%)   9/66 (13.64%)   14/67 (20.90%)   16/68 (23.53%)   17/62 (27.42%)   11/63 (17.46%) 
Cardiac disorders                 
Palpitations * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  1/67 (1.49%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Tachycardia * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Ear and labyrinth disorders                 
Tinnitus * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  1/62 (1.61%)  0/63 (0.00%) 
Vertigo * 1  2/142 (1.41%)  1/32 (3.13%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  2/62 (3.23%)  0/63 (0.00%) 
Eye disorders                 
Vision blurred * 1  0/142 (0.00%)  0/32 (0.00%)  0/47 (0.00%)  0/66 (0.00%)  1/67 (1.49%)  0/68 (0.00%)  2/62 (3.23%)  0/63 (0.00%) 
Gastrointestinal disorders                 
Abdominal discomfort * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Abdominal pain upper * 1  2/142 (1.41%)  0/32 (0.00%)  1/47 (2.13%)  2/66 (3.03%)  0/67 (0.00%)  1/68 (1.47%)  1/62 (1.61%)  0/63 (0.00%) 
Diarrhoea * 1  2/142 (1.41%)  1/32 (3.13%)  1/47 (2.13%)  1/66 (1.52%)  0/67 (0.00%)  0/68 (0.00%)  1/62 (1.61%)  0/63 (0.00%) 
Dry mouth * 1  3/142 (2.11%)  0/32 (0.00%)  3/47 (6.38%)  1/66 (1.52%)  2/67 (2.99%)  4/68 (5.88%)  0/62 (0.00%)  1/63 (1.59%) 
Dyspepsia * 1  1/142 (0.70%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  1/68 (1.47%)  1/62 (1.61%)  0/63 (0.00%) 
Hypoaesthesia oral * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Nausea * 1  5/142 (3.52%)  1/32 (3.13%)  2/47 (4.26%)  3/66 (4.55%)  5/67 (7.46%)  3/68 (4.41%)  5/62 (8.06%)  2/63 (3.17%) 
Paraesthesia oral * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Regurgitation * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Vomiting * 1  0/142 (0.00%)  0/32 (0.00%)  3/47 (6.38%)  1/66 (1.52%)  1/67 (1.49%)  0/68 (0.00%)  1/62 (1.61%)  1/63 (1.59%) 
General disorders                 
Chest discomfort * 1  1/142 (0.70%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  1/63 (1.59%) 
Chills * 1  2/142 (1.41%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Fatigue * 1  4/142 (2.82%)  1/32 (3.13%)  2/47 (4.26%)  2/66 (3.03%)  2/67 (2.99%)  4/68 (5.88%)  0/62 (0.00%)  2/63 (3.17%) 
Feeling hot * 1  0/142 (0.00%)  0/32 (0.00%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  2/62 (3.23%)  0/63 (0.00%) 
Irritability * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  2/67 (2.99%)  0/68 (0.00%)  1/62 (1.61%)  0/63 (0.00%) 
Malaise * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Investigations                 
Blood glucose increased * 1  0/142 (0.00%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  1/68 (1.47%)  0/62 (0.00%)  0/63 (0.00%) 
Muscle spasms * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Muscle tightness * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Myalgia * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Pain in extremity * 1  0/142 (0.00%)  0/32 (0.00%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  3/62 (4.84%)  0/63 (0.00%) 
Sensation of heaviness * 1  0/142 (0.00%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Nervous system disorders                 
Dizziness * 1  2/142 (1.41%)  3/32 (9.38%)  4/47 (8.51%)  2/66 (3.03%)  2/67 (2.99%)  2/68 (2.94%)  1/62 (1.61%)  2/63 (3.17%) 
Dysgeusia * 1  1/142 (0.70%)  1/32 (3.13%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  1/68 (1.47%)  0/62 (0.00%)  0/63 (0.00%) 
Headache * 1  0/142 (0.00%)  2/32 (6.25%)  0/47 (0.00%)  0/66 (0.00%)  1/67 (1.49%)  0/68 (0.00%)  3/62 (4.84%)  0/63 (0.00%) 
Hyperaesthesia * 1  0/142 (0.00%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Hypoaesthesia * 1  0/142 (0.00%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  2/68 (2.94%)  1/62 (1.61%)  1/63 (1.59%) 
Paraesthesia * 1  1/142 (0.70%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  1/63 (1.59%) 
Somnolence * 1  2/142 (1.41%)  1/32 (3.13%)  2/47 (4.26%)  0/66 (0.00%)  2/67 (2.99%)  3/68 (4.41%)  0/62 (0.00%)  0/63 (0.00%) 
Tremor * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  1/63 (1.59%) 
Psychiatric disorders                 
Aggression * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Anxiety * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Insomnia * 1  1/142 (0.70%)  1/32 (3.13%)  0/47 (0.00%)  1/66 (1.52%)  0/67 (0.00%)  1/68 (1.47%)  0/62 (0.00%)  1/63 (1.59%) 
Panic attack * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Oropharyngeal pain * 1  1/142 (0.70%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  1/62 (1.61%)  0/63 (0.00%) 
Throat tightness * 1  0/142 (0.00%)  0/32 (0.00%)  2/47 (4.26%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Yawning * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Skin and subcutaneous tissue disorders                 
Erythema * 1  1/142 (0.70%)  1/32 (3.13%)  0/47 (0.00%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  1/63 (1.59%) 
Pruritus * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  1/67 (1.49%)  1/68 (1.47%)  0/62 (0.00%)  1/63 (1.59%) 
Urticaria * 1  0/142 (0.00%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  0/63 (0.00%) 
Vascular disorders                 
Flushing * 1  1/142 (0.70%)  0/32 (0.00%)  1/47 (2.13%)  0/66 (0.00%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  1/63 (1.59%) 
Hot flush * 1  0/142 (0.00%)  0/32 (0.00%)  0/47 (0.00%)  1/66 (1.52%)  0/67 (0.00%)  0/68 (0.00%)  0/62 (0.00%)  2/63 (3.17%) 
*
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
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: NCT00712725     History of Changes
Other Study ID Numbers: 3207-005
2008_536
First Submitted: July 8, 2008
First Posted: July 10, 2008
Results First Submitted: October 22, 2010
Results First Posted: November 22, 2010
Last Update Posted: February 2, 2015