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A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

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: NCT00246337
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : September 15, 2010
Last Update Posted : November 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: Comparator: Placebo
Drug: MK0974
Drug: Rizatriptan
Enrollment 420
Recruitment Details 20 centers from the United States participated. First Patient treated on 01 December 2005; Last Patient Last Treatment was on 01 May 2006.
Pre-assignment Details Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Period Title: Overall Study
Started 147 16 18 17 16 54 54 53 45
Completed Period (Initial Dose) 46 4 9 5 8 29 29 27 19
Completed Period (Both Doses) 69 10 6 11 4 10 16 13 15
Completed 115 14 15 16 12 39 45 40 34
Not Completed 32 2 3 1 4 15 9 13 11
Reason Not Completed
Lost to Follow-up             3             0             0             0             2             2             1             2             0
Protocol Violation             1             0             0             0             1             0             1             1             0
Withdrawal by Subject             2             0             0             0             0             0             1             1             0
Lack of Qualifying Event             8             2             1             1             1             3             3             2             5
Site Terminated             10             0             0             0             0             7             1             6             2
Abnormal baseline lab values             7             0             2             0             0             2             2             0             4
Overwhelmed             0             0             0             0             0             1             0             0             0
Protocol Violator             1             0             0             0             0             0             0             0             0
Reported as completing trial in error             0             0             0             0             0             0             0             1             0
Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg Total
Hide Arm/Group Description

Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

The reported number of participants are all patients randomized who received study drug and completed the study.

Total of all reporting groups
Overall Number of Baseline Participants 115 14 15 16 12 39 45 40 34 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 14 participants 15 participants 16 participants 12 participants 39 participants 45 participants 40 participants 34 participants 330 participants
42.2  (10.6) 43.0  (10.1) 41.5  (10.9) 40.9  (7.5) 34.3  (11.7) 40.5  (10.4) 40.1  (11.9) 44.5  (12.0) 40.2  (10.8) 41.5  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 14 participants 15 participants 16 participants 12 participants 39 participants 45 participants 40 participants 34 participants 330 participants
Female
104
  90.4%
11
  78.6%
14
  93.3%
14
  87.5%
9
  75.0%
34
  87.2%
42
  93.3%
36
  90.0%
28
  82.4%
292
  88.5%
Male
11
   9.6%
3
  21.4%
1
   6.7%
2
  12.5%
3
  25.0%
5
  12.8%
3
   6.7%
4
  10.0%
6
  17.6%
38
  11.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 14 participants 15 participants 16 participants 12 participants 39 participants 45 participants 40 participants 34 participants 330 participants
White 92 10 11 11 6 29 34 38 28 259
Black 18 4 3 3 5 7 10 2 5 57
Asian 0 0 0 1 0 0 1 0 0 2
American Indian or Alaska Native 1 0 0 0 0 0 0 0 0 1
European 0 0 0 0 0 0 0 0 1 1
Hispanic American 4 0 0 1 1 3 0 0 0 9
Multi-Racial 0 0 1 0 0 0 0 0 0 1
Baseline Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 115 participants 14 participants 15 participants 16 participants 12 participants 39 participants 45 participants 40 participants 34 participants 330 participants
Moderate 81 11 9 15 6 26 34 30 27 239
Severe 34 3 6 1 6 12 11 10 7 90
Baseline Severity data missing 0 0 0 0 0 1 0 0 0 1
[1]
Measure Description: Baseline severity was self-reported by the participant and recorded in the take-home diary. Migraine pain was rated on a 4-point scale (No Pain=0, Mild Pain=1, Moderate Pain=2, Severe Pain=3).
1.Primary Outcome
Title Pain Relief at 2 Hours
Hide Description Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description

All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.

One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.

Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description:
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 115 14 15 16 12 38 45 40 34
Measure Type: Number
Unit of Measure: Participants
52 5 9 8 5 25 22 27 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg
Comments Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments 0.05 is the pre-specified significance level.
Method generalized linear model
Comments The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.
2.Secondary Outcome
Title Pain Freedom at 2 Hours
Hide Description Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
Time Frame 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description

All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.

One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.

Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description:
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 115 14 15 16 12 38 45 40 34
Measure Type: Number
Unit of Measure: Participants
16 3 7 3 2 17 11 13 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg
Comments Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 0.05 is the pre-specified significance level.
Method generalized linear model
Comments The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.
3.Secondary Outcome
Title Sustained Pain Relief
Hide Description Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Time Frame 2-24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description

All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.

One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing

Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description:
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 115 13 15 16 11 38 45 40 34
Measure Type: Number
Unit of Measure: Participants
27 1 9 3 3 20 17 21 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg
Comments Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 0.05 is the pre-specified significance level.
Method generalized linear model
Comments [Not Specified]
4.Secondary Outcome
Title Sustained Pain Freedom
Hide Description Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Time Frame 2-24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description

All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.

One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.

Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description:
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Overall Number of Participants Analyzed 115 13 15 16 11 38 45 40 34
Measure Type: Number
Unit of Measure: Participants
12 1 7 3 1 15 10 13 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg
Comments Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 0.05 is the pre-specified significance level.
Method generalized linear model
Comments The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.
Time Frame Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
Adverse Event Reporting Description For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
 
Arm/Group Title Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 mg
Hide Arm/Group Description Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
All-Cause Mortality
Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 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 (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 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 (%) Affected / at Risk (%)
Total   1/47 (2.13%)   0/17 (0.00%)   0/19 (0.00%)   0/27 (0.00%)   0/18 (0.00%)   0/51 (0.00%)   0/52 (0.00%)   0/49 (0.00%)   0/50 (0.00%) 
Infections and infestations                   
Appendicitis * 1  1/47 (2.13%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo MK0974 25 mg MK0974 50 mg MK0974 100 mg MK0974 200 mg MK0974 300 mg MK0974 400 mg MK0974 600 mg Rizatriptan 10 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 (%) Affected / at Risk (%)
Total   10/47 (21.28%)   4/17 (23.53%)   9/19 (47.37%)   4/27 (14.81%)   7/18 (38.89%)   9/51 (17.65%)   12/52 (23.08%)   14/49 (28.57%)   10/50 (20.00%) 
Cardiac disorders                   
Sinus tachycardia * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Ear and labyrinth disorders                   
Tinnitus * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Eye disorders                   
Eye pain * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Gastrointestinal disorders                   
Dry mouth * 1  1/47 (2.13%)  1/17 (5.88%)  0/19 (0.00%)  1/27 (3.70%)  0/18 (0.00%)  2/51 (3.92%)  2/52 (3.85%)  1/49 (2.04%)  1/50 (2.00%) 
Flatulence * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  1/27 (3.70%)  0/18 (0.00%)  0/51 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Nausea * 1  6/47 (12.77%)  0/17 (0.00%)  0/19 (0.00%)  1/27 (3.70%)  0/18 (0.00%)  3/51 (5.88%)  5/52 (9.62%)  5/49 (10.20%)  1/50 (2.00%) 
Vomiting * 1  1/47 (2.13%)  1/17 (5.88%)  0/19 (0.00%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  2/52 (3.85%)  1/49 (2.04%)  0/50 (0.00%) 
General disorders                   
Fatigue * 1  0/47 (0.00%)  1/17 (5.88%)  3/19 (15.79%)  2/27 (7.41%)  0/18 (0.00%)  0/51 (0.00%)  1/52 (1.92%)  1/49 (2.04%)  2/50 (4.00%) 
Infections and infestations                   
Upper respiratory tract infection * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  1/52 (1.92%)  0/49 (0.00%)  0/50 (0.00%) 
Investigations                   
Platelet count increased * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders                   
Food craving * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Musculoskeletal stiffness * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Nervous system disorders                   
Dizziness * 1  2/47 (4.26%)  0/17 (0.00%)  2/19 (10.53%)  0/27 (0.00%)  2/18 (11.11%)  3/51 (5.88%)  1/52 (1.92%)  4/49 (8.16%)  1/50 (2.00%) 
Dysgeusia * 1  1/47 (2.13%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  1/50 (2.00%) 
Hyperaesthesia * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  1/50 (2.00%) 
Paraesthesia * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  1/49 (2.04%)  2/50 (4.00%) 
Somnolence * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  1/27 (3.70%)  2/18 (11.11%)  2/51 (3.92%)  1/52 (1.92%)  4/49 (8.16%)  2/50 (4.00%) 
Psychiatric disorders                   
Bruxism * 1  0/47 (0.00%)  0/17 (0.00%)  1/19 (5.26%)  0/27 (0.00%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Restlessness * 1  0/47 (0.00%)  0/17 (0.00%)  0/19 (0.00%)  0/27 (0.00%)  1/18 (5.56%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Rhinorrhoea * 1  0/47 (0.00%)  1/17 (5.88%)  0/19 (0.00%)  1/27 (3.70%)  0/18 (0.00%)  0/51 (0.00%)  0/52 (0.00%)  0/49 (0.00%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00246337     History of Changes
Other Study ID Numbers: 0974-004
2005_082
First Submitted: October 27, 2005
First Posted: October 31, 2005
Results First Submitted: July 19, 2010
Results First Posted: September 15, 2010
Last Update Posted: November 2, 2015