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A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

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ClinicalTrials.gov Identifier: NCT00758836
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 11, 2014
Last Update Posted : October 22, 2018
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: placebo
Drug: ibuprofen
Drug: acetominophen
Drug: telcagepant
Enrollment 683
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Period Title: Overall Study
Started 171 171 171 170
Treated 147 145 133 138
Completed 147 145 133 138
Not Completed 24 26 38 32
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg Total
Hide Arm/Group Description Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine Total of all reporting groups
Overall Number of Baseline Participants 171 171 171 170 683
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 171 participants 171 participants 170 participants 683 participants
<20 years 4 0 3 3 10
20-29 years 34 43 32 33 142
30-39 years 33 47 37 53 170
40-49 years 58 51 49 51 209
50-59 years 32 19 42 23 116
60-64 years 4 6 6 2 18
>=65 years 6 5 2 5 18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 171 participants 171 participants 170 participants 683 participants
Female
150
  87.7%
139
  81.3%
149
  87.1%
145
  85.3%
583
  85.4%
Male
21
  12.3%
32
  18.7%
22
  12.9%
25
  14.7%
100
  14.6%
1.Primary Outcome
Title Percentage of Participants With Pain Freedom at Two Hours Post-dose
Hide Description Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description:
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Overall Number of Participants Analyzed 147 145 133 138
Measure Type: Number
Unit of Measure: Percentage of Participants
10.9 35.2 38.3 31.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg +Ibuprofen 400 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 24.5
Confidence Interval (2-Sided) 90%
16.7 to 32.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg +APAP 1000 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 27.7
Confidence Interval (2-Sided) 90%
19.6 to 35.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 20.4
Confidence Interval (2-Sided) 90%
12.6 to 28.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 mg +Ibuprofen 400 mg, Telcagepant 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion differenece
Estimated Value 4.2
Confidence Interval (2-Sided) 90%
-5.0 to 13.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 mg +APAP 1000 mg, Telcagepant 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 7.7
Confidence Interval (2-Sided) 90%
-1.8 to 17.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame Up to 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description:
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Overall Number of Participants Analyzed 148 145 133 137
Measure Type: Number
Unit of Measure: Participants
27 44 42 34
3.Primary Outcome
Title Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame Up to 14 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description:
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Overall Number of Participants Analyzed 148 145 133 137
Measure Type: Number
Unit of Measure: participants
31 46 46 37
4.Secondary Outcome
Title Percentage of Participants With Pain Relief at 2 Hours Post-dose.
Hide Description Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description:
Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Overall Number of Participants Analyzed 147 145 133 138
Measure Type: Number
Unit of Measure: Percentage of Participants
30.6 71.0 69.9 65.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg +Ibuprofen 400 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 40.8
Confidence Interval (2-Sided) 90%
31.9 to 49.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg +APAP 1000 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 39.9
Confidence Interval (2-Sided) 90%
30.5 to 48.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 mg +Ibuprofen 400 mg, Telcagepant 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments [Not Specified]
Method Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 6.1
Confidence Interval (2-Sided) 90%
-2.9 to 14.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Telcagepant 280 mg +APAP 1000 mg, Telcagepant 280 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments [Not Specified]
Method Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 5.2
Confidence Interval (2-Sided) 90%
-4.2 to 14.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Telcagepant 280 mg
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 Miettinen and Nurminen
Comments Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.
Method of Estimation Estimation Parameter Proportion difference
Estimated Value 34.7
Confidence Interval (2-Sided) 90%
25.3 to 43.4
Estimation Comments [Not Specified]
Time Frame Up to 14 days after the dose was taken.
Adverse Event Reporting Description One participant randomly assigned to the Telcagepant 280 mg arm took only the placebp tablet and is included in the Placebo arm for adverse event reporting.
 
Arm/Group Title Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Hide Arm/Group Description Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
All-Cause Mortality
Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/148 (0.00%)      0/145 (0.00%)      0/133 (0.00%)      0/137 (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 Telcagepant 280 mg +Ibuprofen 400 mg Telcagepant 280 mg +APAP 1000 mg Telcagepant 280 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/148 (8.11%)      23/145 (15.86%)      16/133 (12.03%)      16/137 (11.68%)    
Gastrointestinal disorders         
Nausea  1  8/148 (5.41%)  8 9/145 (6.21%)  9 5/133 (3.76%)  5 6/137 (4.38%)  6
General disorders         
Fatigue  1  1/148 (0.68%)  1 8/145 (5.52%)  9 7/133 (5.26%)  7 4/137 (2.92%)  4
Nervous system disorders         
Somnolence  1  3/148 (2.03%)  3 8/145 (5.52%)  8 5/133 (3.76%)  5 6/137 (4.38%)  6
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.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
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: NCT00758836     History of Changes
Other Study ID Numbers: 0974-046
2008_551 ( Other Identifier: Merck Registration Number )
CTRI/2009/091/000291 ( Registry Identifier: CTRI )
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: July 18, 2014
Results First Posted: August 11, 2014
Last Update Posted: October 22, 2018