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Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents

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ClinicalTrials.gov Identifier: NCT00488514
Recruitment Status : Completed
First Posted : June 20, 2007
Results First Posted : September 6, 2010
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Intervention Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Enrollment 656
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
Hide Arm/Group Description Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
Period Title: Overall Study
Started 656
Completed 363
Not Completed 293
Reason Not Completed
Adverse Event             41
Lost to Follow-up             44
Protocol Violation             32
Withdrawal by Subject             106
Lack of Efficacy             28
Did not meet criteria for treatment             30
Postive drug screen             1
Withdrawn per medical monitor decision             2
Investigator decision             1
Participant had too few migraines             5
Increase in number of migraines             2
Increased use of concomitant medication             1
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
Hide Arm/Group Description Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
Overall Number of Baseline Participants 622
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 622 participants
14.7  (1.68)
[1]
Measure Description: Baseline data were collected in the Safety Population, comprised of all participants in the Enrolled Population (all participants entered into the trial and categorized as "started" in the Participant Flow module) who took at least one dose of study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 622 participants
Female
367
  59.0%
Male
255
  41.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 622 participants
Caucasian 527
Africian American 71
American Indian or Alaskan Native 10
Asian 4
African American/African Heritage and Asian 2
African American/African Heritage and White 3
American Indian or Alaskan Native and White 5
1.Primary Outcome
Title Number of Participants With the Indicated Drug-related Adverse Events
Hide Description The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: participants
At least one drug-related adverse event 93 46 170
Nausea 19 11 44
Dizziness 7 3 20
Muscle tightness 10 5 18
Chest discomfort 10 3 16
Paresthesia 8 2 14
Throat tightness 11 6 14
Somnolence 9 2 14
Neck pain 6 3 12
Flushing 5 2 8
2.Secondary Outcome
Title Number of Participants With Any Adverse Event Categorized by Severity
Hide Description The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: participants
Mild 74 43 127
Moderate 140 72 220
Severe 24 14 44
3.Secondary Outcome
Title Number of Participants With Any Adverse Event Categorized Over Time
Hide Description The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: participants
First six months of study 208 112 348
Second six months of study 143 85 191
4.Secondary Outcome
Title Number of Participants With Any Adverse Event Categorized by Participant Age
Hide Description The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: participants
Ages 12-14 104 57 175
Ages 15-17 135 73 218
5.Secondary Outcome
Title Number of Participants With Any Adverse Event Categorized by Participant Race
Hide Description The number of participants with any adverse event was categorized by race. The category "Other" captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
Hide Arm/Group Description:
Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
Overall Number of Participants Analyzed 622
Measure Type: Number
Unit of Measure: participants
Caucasian 344
African American 35
Other 14
6.Secondary Outcome
Title Number of Participants With Any Adverse Event Categorized by Participant Gender
Hide Description The number of participants with adverse events by gender is recorded.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
Hide Arm/Group Description:
Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
Overall Number of Participants Analyzed 622
Measure Type: Number
Unit of Measure: participants
Female 238
Male 155
7.Secondary Outcome
Title Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet
Hide Description The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: participants
Within 3 days 66 35 128
Within 5 days 66 35 130
8.Secondary Outcome
Title Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet
Hide Description The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 333 181 622
Measure Type: Number
Unit of Measure: tablets
Number of tablets with an AE within 3 days 917 667 1116
Number of tablets with an AE within 5 days 970 706 1178
9.Secondary Outcome
Title Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
Hide Description A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 330 179 565
Measure Type: Number
Unit of Measure: participants
ALT, normal to high, n=330, 179, 565 2 1 3
ALT, normal to low, n=330, 179, 565 0 0 0
AST, normal to high, n=329, 179, 562 1 1 3
AST, normal to low, n=329, 179, 562 0 0 0
Creatinine, normal to high, n=330, 179, 565 0 0 0
Creatinine, normal to low, n=330, 179, 565 2 1 2
Potassium, normal to high, n=329, 179, 562 1 0 4
Potassium, normal to low, n=329, 179, 562 3 2 6
BUN, normal to high, n=330, 179, 565 0 0 1
BUN, normal to low, n=330, 179, 565 2 0 9
10.Secondary Outcome
Title Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
Hide Description A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 6 Month Completer Population 12 Month Completer Population Safety Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet
Overall Number of Participants Analyzed 318 176 546
Measure Type: Number
Unit of Measure: participants
Hemoglobin, normal to high, n=318,176, 546 6 0 9
Hemoglobin, normal to low, n=318,176, 546 10 6 20
Hematocrit, normal to high, n=318,176, 546 2 0 4
Hematocrit, normal to low, n=318,176, 546 17 10 29
11.Secondary Outcome
Title Mean Height for All Study Participants at the Indicated Time Points
Hide Description [Not Specified]
Time Frame Screening and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 285 337 622
Mean (Standard Deviation)
Unit of Measure: centimeters
Screening, n=285, 337, 622 160.2  (9.15) 167.0  (8.80) 163.9  (9.57)
Month 3, n=271, 308, 579 161.3  (9.09) 167.3  (8.92) 164.5  (9.48)
Month 6, n=224, 249, 473 162.6  (9.12) 167.3  (8.81) 165.1  (9.26)
Month 9, n=198, 221, 419 163.8  (8.92) 167.6  (8.39) 165.8  (8.84)
Month 12, n=178, 198, 376 165.3  (8.86) 167.9  (8.70) 166.7  (8.86)
12.Secondary Outcome
Title Mean Weight for All Study Participants at the Indicated Time Points
Hide Description [Not Specified]
Time Frame Screening and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 285 337 622
Mean (Standard Deviation)
Unit of Measure: kilograms
Screening, n=285, 337, 622 57.02  (15.450) 66.57  (16.824) 62.19  (16.881)
Month 3, n=270, 306, 576 58.01  (16.012) 66.61  (16.921) 62.58  (17.037)
Month 6, n=223, 248, 471 60.20  (16.976) 66.61  (16.864) 63.57  (17.200)
Month 9, n=197, 220, 417 61.24  (17.149) 66.90  (17.169) 64.23  (17.372)
Month 12, n=178, 198, 376 62.92  (17.406) 67.35  (17.952) 65.25  (17.810)
13.Secondary Outcome
Title Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points
Hide Description BMI = (Weight in kilograms)/(height in centimeters/100)^2
Time Frame Screening and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 285 337 622
Mean (Standard Deviation)
Unit of Measure: kilograms per meters squared
Screening, n=285, 337, 622 22.01  (4.611) 23.77  (5.249) 22.97  (5.040)
Month 3, n=270, 306, 576 22.09  (4.740) 23.71  (5.267) 22.95  (5.087)
Month 6, n=223, 248, 471 22.54  (4.949) 23.74  (5.455) 23.17  (5.251)
Month 9, n= 197, 220, 417 22.58  (4.904) 23.74  (5.431) 23.20  (5.215)
Month 12, n=178, 198, 376 22.81  (4.969) 23.79  (5.633) 23.33  (5.345)
14.Secondary Outcome
Title Mean Blood Pressure for All Study Participants at the Indicated Time Points
Hide Description At each visit, a participant’s blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.
Time Frame Screening and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 285 337 622
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
SBP, Screening, n=285, 337, 622 107.4  (10.08) 110.2  (10.15) 108.9  (10.21)
SBP, Month 3, n=270, 308, 578 107.2  (10.67) 111.1  (10.19) 109.3  (10.58)
SBP, Month 6, n=224, 249, 473 109.2  (10.37) 112.0  (10.39) 110.6  (10.46)
SBP, Month 9, n=198, 221, 419 109.6  (10.55) 112.7  (10.63) 111.2  (10.69)
SBP, Month 12, n=178, 198, 376 111.0  (10.78) 112.1  (10.22) 111.5  (10.49)
DBP, Screening, n=285, 337, 622 66.2  (7.72) 69.0  (7.24) 67.7  (7.58)
DBP, Month 3, n=270, 308, 578 65.7  (7.33) 68.4  (7.84) 67.1  (7.72)
DBP, Month 6, n=224, 249, 473 66.1  (7.29) 68.4  (7.68) 67.3  (7.58)
DBP, Month 9, n=198, 221, 419 65.6  (6.79) 68.9  (7.30) 67.3  (7.25)
DBP, Month 12, n=178, 198, 376 66.6  (8.40) 69.9  (7.35) 68.3  (8.03)
15.Secondary Outcome
Title Mean Heart Rate for All Study Participants at the Indicated Time Points
Hide Description A sitting heart rate was measured once for each participant at each visit.
Time Frame Screening and Months 3, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 284 336 620
Mean (Standard Deviation)
Unit of Measure: beats per minute
Screening, n=284, 336, 620 75.8  (11.58) 73.0  (10.20) 7.43  (10.93)
Month 3, n=266, 305, 571 76.9  (11.57) 75.6  (11.57) 76.2  (11.58)
Month 6, n=221, 247, 468 77.5  (10.87) 75.4  (10.22) 76.4  (10.57)
Month 9, n=198, 221, 419 76.9  (11.43) 75.4  (11.13) 76.1  (11.28)
Month 12, n=178, 198, 376 76.8  (12.17) 74.7  (10.41) 75.7  (11.31)
16.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator
Hide Description The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.
Time Frame Screening and Final Visit (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
Arm/Group Title 12-14 Years 15-17 Years 12-17 Years
Hide Arm/Group Description:
Participants who were 12-14 years old at the time of the Screening Visit
Participants who were 15-17 years old at the time of the Screening Visit
All participants in the Enrolled Population who took at least one dose of study drug
Overall Number of Participants Analyzed 284 337 621
Measure Type: Number
Unit of Measure: participants
Screening, normal, n=284, 337, 621 224 270 494
Screening, abnormal, NCS, n=284, 337, 621 60 67 127
Screening, abnormal, CS, n=284, 337, 621 0 0 0
Final Visit, Normal, n=248, 294, 542 196 220 416
Final Visit, abnormal, NCS, n=248, 294, 542 52 74 126
Final Visit, abnormal, CS, n=248, 294, 542 0 0 0
17.Secondary Outcome
Title Number of Treated Migraine Attacks
Hide Description The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John’s Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.
Time Frame Baseline through End of Study (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
Hide Arm/Group Description:
Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
Overall Number of Participants Analyzed 591
Measure Type: Number
Unit of Measure: treated migraine attacks
All Migraines 8517
Migraines Without Rescue Medication 7791
Migraines Without Rescue or Prohibited Medication 7657
18.Secondary Outcome
Title Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet
Hide Description The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.
Time Frame Baseline through End of Study (up to Month 12)
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ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
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[Not Specified]
Overall Number of Participants Analyzed 591
Measure Type: Number
Unit of Measure: treated migraine attacks
All Migraines 6400
Migraines Without Rescue Medication 6142
Migraines Without Rescue or Prohibited Medication 6052
19.Secondary Outcome
Title Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet
Hide Description The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.
Time Frame Baseline through End of Study (up to Month 12)
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ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
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Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
Overall Number of Participants Analyzed 591
Measure Type: Number
Unit of Measure: treated migraine attacks
All Migraines 5076
Migraines Without Rescue Medication 5020
Migraines Without Rescue or Prohibited Medication 5017
20.Secondary Outcome
Title Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet
Hide Description The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.
Time Frame Baseline through End of Study (up to Month 12)
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ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
Arm/Group Title 85 mg Sumatriptan/500 mg Naproxen Sodium
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Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
Overall Number of Participants Analyzed 591
Measure Type: Number
Unit of Measure: treated migraine attacks
All Migraines 3623
Migraines Without Rescue Medication 3598
Migraines Without Rescue or Prohibited Medication 3596
21.Secondary Outcome
Title Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month
Hide Description The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.
Time Frame Baseline through End of Study (up to Month 12)
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population ITT Population
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Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Overall Number of Participants Analyzed 333 181 591
Mean (Standard Deviation)
Unit of Measure: events
Headaches 3.3  (2.19) 3.9  (2.29) 3.0  (2.49)
Migraines 2.2  (1.17) 2.6  (1.09) 1.8  (1.23)
Treated migraine attacks 1.9  (1.05) 2.4  (0.97) 1.5  (1.11)
22.Secondary Outcome
Title Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet
Hide Description The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.
Time Frame Baseline through End of Study (up to Month 12)
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population ITT Population
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Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Overall Number of Participants Analyzed 333 181 591
Measure Type: Number
Unit of Measure: migraine attacks
Total Migraines 8290 5851 9937
Treated Migraines 7318 5234 8517
23.Secondary Outcome
Title Number of Migraine Attacks Rated With the Indicated Pain Severity
Hide Description The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.
Time Frame Baseline through End of Study (up to Month 12)
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population ITT Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Overall Number of Participants Analyzed 333 181 591
Measure Type: Number
Unit of Measure: treated migraine attacks
No pain 0 0 0
Mild 1373 1009 1619
Moderate 3555 2535 4132
Severe 2385 1686 2759
24.Secondary Outcome
Title Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting
Hide Description The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.
Time Frame Baseline through End of Study (up to Month 12)
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
Arm/Group Title 6 Month Completer Population 12 Month Completer Population ITT Population
Hide Arm/Group Description:
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Overall Number of Participants Analyzed 333 181 591
Measure Type: Number
Unit of Measure: treated migraine attacks
Photophobia 5608 4064 6528
Phonophobia 5221 3725 6063
Nausea 3120 2173 3690
Neck pain 3050 2172 3540
Sinus pain 2052 1424 2428
Vomiting 555 375 682
25.Secondary Outcome
Title Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12
Hide Description The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.
Time Frame Baseline and Months 3, 6, 9, and 12
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
Arm/Group Title ITT Population 12 Month Completer Population
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Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Overall Number of Participants Analyzed 457 160
Mean (Standard Error)
Unit of Measure: points on a scale
Role restrictive, Month 3, n=457, 160 10.1  (1.145) 9.0  (1.952)
Role restrictive, Month 6, n=366, 160 10.5  (1.302) 8.2  (1.972)
Role restrictive, Month 9, n=315, 148 13.7  (1.475) 9.0  (2.155)
Role restrictive, Month 12, n=291, 153 15.7  (1.530) 11.5  (2.117)
Role preventative, Month 3, n=457, 160 7.9  (1.110) 9.6  (1.974)
Role preventative, Month 6, n=366, 160 6.8  (1.212) 8.3  (1.890)
Role preventative, Month 9, n=315, 148 9.4  (1.473) 8.2  (2.234)
Role preventative, Month 12, n=291, 153 9.8  (1.441) 8.4  (1.959)
Role emotional , Month 3, n=457, 160 7.1  (1.287) 7.9  (2.223)
Role emotional, Month 6, n=366, 160 6.6  (1.441) 7.2  (2.136)
Role emotional, Month 9, n=315, 148 10.5  (1.625) 9.0  (2.411)
Role emotional, Month 12, n=291, 153 11.4  (1.694) 7.1  (2.461)
26.Secondary Outcome
Title Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire–Revised (PPMQ-R) at the Screening Visit
Hide Description The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).
Time Frame Screening
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
Arm/Group Title ITT Population 6 Month Completer Population 12 Month Completer Population
Hide Arm/Group Description:
Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Overall Number of Participants Analyzed 562 316 174
Measure Type: Number
Unit of Measure: participants
Overall Efficacy, Very Satisfied 36 22 11
Overall Efficacy, Satisfied 163 102 54
Overall Efficacy, Somewhat Satisfied 192 113 72
Overall Efficacy, Neutral 67 30 15
Overall Efficacy, Somewhat Dissatisfied 49 23 12
Overall Efficacy, Dissatisfied 43 22 8
Overall Efficacy, Very Dissatisfied 12 4 2
Side Effects, Very Satisfied 135 89 50
Side Effects, Satisfied 166 87 50
Side Effects, Somewhat Satisfied 77 45 26
Side Effects, Neutral 127 69 36
Side Effects, Somewhat Dissatisfied 29 13 6
Side Effects, Dissatisfied 18 6 2
Side Effects, Very Dissatisfied 11 7 4
Overall Treatment Satisfaction, Very Satisfied 50 30 11
Overall Treatment Satisfaction, Satisfied 192 113 70
Overall Treatment Satisfaction, Somewhat Satisfied 164 94 56
Overall Treatment Satisfaction, Neutral 67 35 16
Treatment Satisfaction, Somewhat Dissatisfied 31 13 9
Overall Treatment Satisfaction, Dissatisfied 43 23 9
Overall Treatment Satisfaction, Very Dissatisfied 15 8 3
27.Secondary Outcome
Title Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire–Revised (PPMQ-R) at Month 12
Hide Description The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).
Time Frame End of Study/Month 12
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Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
Arm/Group Title ITT Population 6 Month Completer Population 12 Month Completer Population
Hide Arm/Group Description:
Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
Overall Number of Participants Analyzed 171 144 110
Measure Type: Number
Unit of Measure: participants
Overall Efficacy, Very Satisfied 66 59 48
Overall Efficacy, Satisfied 75 63 46
Overall Efficacy, Somewhat Satisfied 20 16 12
Overall Efficacy, Neutral 7 5 3
Overall Efficacy, Somewhat Dissatisfied 2 1 1
Overall Efficacy, Dissatisfied 1 0 0
Overall Efficacy, Very Dissatisfied 0 0 0
Side Effects, Very Satisfied 55 49 42
Side Effects, Satisfied 61 51 40
Side Effects, Somewhat Satisfied 24 21 14
Side Effects, Neutral 11 10 6
Side Effects, Somewhat Dissatisfied 12 7 3
Side Effects, Dissatisfied 5 4 3
Side Effects, Very Dissatisfied 3 2 2
Overall Treatment Satisfaction, Very Satisfied 71 64 51
Overall Treatment Satisfaction, Satisfied 76 61 47
Overall Treatment Satisfaction, Somewhat Satisfied 13 10 6
Overall Treatment Satisfaction, Neutral 6 5 2
Treatment Satisfaction, Somewhat Dissatisfied 3 3 3
Overall Treatment Satisfaction, Dissatisfied 1 0 0
Overall Treatment Satisfaction, Very Dissatisfied 1 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safety Population 6 Month Completer Population 12 Month Completer Population
Hide Arm/Group Description Participants in the Enrolled Population who took at least one dose of the combination tablet Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
All-Cause Mortality
Safety Population 6 Month Completer Population 12 Month Completer Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Safety Population 6 Month Completer Population 12 Month Completer Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/622 (0.64%)   3/333 (0.90%)   1/181 (0.55%) 
Blood and lymphatic system disorders       
Hemolytic anemia  1  1/622 (0.16%)  1/333 (0.30%)  1/181 (0.55%) 
Nervous system disorders       
Syncope  1  1/622 (0.16%)  1/333 (0.30%)  1/181 (0.55%) 
Pregnancy, puerperium and perinatal conditions       
Spontaneous abortion  1  1/622 (0.16%)  0/333 (0.00%)  0/181 (0.00%) 
Psychiatric disorders       
Suicide attempt  1  1/622 (0.16%)  1/333 (0.30%)  0/181 (0.00%) 
Suicidal ideation  1  1/622 (0.16%)  1/333 (0.30%)  0/181 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Safety Population 6 Month Completer Population 12 Month Completer Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   257/622 (41.32%)   159/333 (47.75%)   89/181 (49.17%) 
Gastrointestinal disorders       
Nausea  1  55/622 (8.84%)  28/333 (8.41%)  16/181 (8.84%) 
General disorders       
Pyrexia  1  14/622 (2.25%)  12/333 (3.60%)  5/181 (2.76%) 
Infections and infestations       
Upper respiratory tract infection  1  54/622 (8.68%)  39/333 (11.71%)  22/181 (12.15%) 
Nasopharyngitis  1  48/622 (7.72%)  35/333 (10.51%)  20/181 (11.05%) 
Sinusitis  1  37/622 (5.95%)  27/333 (8.11%)  19/181 (10.50%) 
Musculoskeletal and connective tissue disorders       
Neck pain  1  24/622 (3.86%)  12/333 (3.60%)  8/181 (4.42%) 
Arthralgia  1  21/622 (3.38%)  16/333 (4.80%)  10/181 (5.52%) 
Muscle tightness  1  20/622 (3.22%)  12/333 (3.60%)  6/181 (3.31%) 
Back pain  1  18/622 (2.89%)  13/333 (3.90%)  7/181 (3.87%) 
Nervous system disorders       
Dizziness  1  25/622 (4.02%)  10/333 (3.00%)  3/181 (1.66%) 
Migraine (worsening)  1  22/622 (3.54%)  6/333 (1.80%)  1/181 (0.55%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  19/622 (3.05%)  14/333 (4.20%)  12/181 (6.63%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  22/622 (3.54%)  16/333 (4.80%)  10/181 (5.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00488514     History of Changes
Other Study ID Numbers: TXA107977
First Submitted: June 18, 2007
First Posted: June 20, 2007
Results First Submitted: August 6, 2010
Results First Posted: September 6, 2010
Last Update Posted: May 18, 2017