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Trial record 29 of 41 for:    FROVATRIPTAN

Treximet ™ Pharmacy Budget Impact Model Database Validation Study

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: NCT01332500
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : April 11, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Migraine Disorders
Interventions Drug: Sumatriptan/Naproxen combination
Drug: other oral triptans
Enrollment 61737
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Hide Arm/Group Description Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Period Title: Overall Study
Started 13257 39771 2903 5806
Completed 13257 39771 2903 5806
Not Completed 0 0 0 0
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan Total
Hide Arm/Group Description Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.

Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.

Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.

Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. Total of all reporting groups
Overall Number of Baseline Participants 13257 39771 2903 5806 61737
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13257 participants 39771 participants 2903 participants 5806 participants 61737 participants
18-30 years old 2889 8867 464 1026 13246
31-40 years old 3425 10172 669 1251 15517
41-50 years old 3700 10887 943 1763 17293
51-60 years old 2315 6993 610 1263 11181
61-70 years old 758 2368 191 428 3745
>70 years old 170 484 26 75 755
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13257 participants 39771 participants 2903 participants 5806 participants 61737 participants
Female
11108
  83.8%
33371
  83.9%
2525
  87.0%
5078
  87.5%
52082
  84.4%
Male
2149
  16.2%
6400
  16.1%
378
  13.0%
728
  12.5%
9655
  15.6%
1.Primary Outcome
Title Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
Hide Description The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 13257 39771
Mean (Standard Deviation)
Unit of Measure: tablets per participant
Triptans 17.7  (16.3) 18.4  (18.2)
Non-steroidal anti-inflammatory drugs 19.2  (57.1) 21.5  (64.9)
Opioids 75.8  (219.0) 80.1  (235.8)
Ergots 0.1  (3.6) 0.1  (2.4)
Other 1.5  (17.0) 1.4  (13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Triptan tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Non-steroidal anti-inflammatory drug tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Opioid tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments Ergot tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments Other tablets
Method paired t-test 2-sided
Comments [Not Specified]
2.Primary Outcome
Title Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Hide Description Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 13257 39771
Mean (Standard Deviation)
Unit of Measure: United States dollars
Triptans 284  (366.1) 333  (393.7)
Non-steroidal anti-inflammatory drugs 9  (62.3) 9  (62.5)
Opioids 38  (609.7) 43  (477.6)
Ergots 2  (33.1) 2  (51.2)
Other 0  (5.1) 0  (4.8)
Total 332  (732.1) 387  (645.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Triptan health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments Non-steroidal anti-inflammatory drug health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments Opioid health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments Ergot health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments Other health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total heath plan costs
Method paired t-test 2-sided
Comments [Not Specified]
3.Primary Outcome
Title Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
Hide Description Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 13257 39771
Mean (Standard Deviation)
Unit of Measure: United States dollars
Triptans 349  (396.4) 397  (418.9)
Non-steroidal anti-inflammatory drugs 11  (69.8) 12  (72.5)
Opioids 49  (621.0) 54  (509.5)
Ergots 2  (36.6) 2  (55.5)
Other 1  (8.6) 1  (7.2)
Total 412  (757.7) 466  (687.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Triptan health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments Non-steroidal, anti-inflammatory drug health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments Opioid health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments Ergot health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments Other health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Naïve - Sumatriptan/Naproxen Sodium, Naïve - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
4.Primary Outcome
Title Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
Hide Description The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 2903 5806
Mean (Standard Deviation)
Unit of Measure: tablets per participant
Triptans 24.4  (20.7) 24.4  (20.2)
Non-steroidal anti-inflammatory drugs 20.9  (62.5) 22.9  (70.9)
Opioids 88.4  (254.7) 87.4  (255.7)
Ergots 0.0  (1.6) 0.1  (3.7)
Other 1.4  (14.9) 1.3  (12.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.866
Comments Triptan tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments Non-steroidal anti-inflammatory drug tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments Opioid tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.392
Comments Ergot tablets
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments Other tablets
Method paired t-test 2-sided
Comments [Not Specified]
5.Primary Outcome
Title Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Hide Description Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 2903 5806
Mean (Standard Deviation)
Unit of Measure: United States dollars
Triptans 375  (374.5) 425  (413.3)
Non-steroidal anti-inflammatory drugs 8  (52.5) 10  (67.2)
Opioids 47  (317.8) 51  (522.9)
Ergots 3  (48.9) 3  (50.1)
Other 0  (6.7) 0  (3.9)
Total 433  (507.4) 490  (695.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Triptan health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments Non-steroidal anti-inflammatory drug health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.590
Comments Opioid health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.382
Comments Ergot health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments Other health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total health plan costs
Method paired t-test 2-sided
Comments [Not Specified]
6.Primary Outcome
Title Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
Hide Description Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.
Time Frame 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)
Hide Outcome Measure Data
Hide Analysis Population Description
The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.
Arm/Group Title Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Hide Arm/Group Description:
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
Overall Number of Participants Analyzed 2903 5806
Mean (Standard Deviation)
Unit of Measure: United States dollars
Triptans 462  (413.3) 496  (439.9)
Non-steroidal anti-inflammatory drugs 12  (62.3) 13  (76.7)
Opioids 61  (360.2) 62  (547.4)
Ergots 3  (51.9) 4  (54.4)
Other 1  (8.5) 1  (6.1)
Total 537  (564.2) 576  (736.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Triptan health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments Non-steroidal anti-inflammatory drug health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments Opioid health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments Ergot health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.514
Comments Other health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Switch - Sumatriptan/Naproxen Sodium, Switch - Oral Triptan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Total health plus copay costs
Method paired t-test 2-sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description This study was a retrospective, observational cohort study with the primary purpose of assessing migraine-specific pharmacy utilization and costs associated with initiating/switching to sumatriptan/naproxen sodium compared to other oral triptans. Therefore, adverse event information was not captured.
 
Arm/Group Title Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Hide Arm/Group Description Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.

Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.

Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.

Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics. Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
All-Cause Mortality
Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naïve - Sumatriptan/Naproxen Sodium Naïve - Oral Triptan Switch - Sumatriptan/Naproxen Sodium Switch - Oral Triptan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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.
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332500     History of Changes
Other Study ID Numbers: 111208
First Submitted: March 21, 2011
First Posted: April 11, 2011
Results First Submitted: March 21, 2011
Results First Posted: April 11, 2011
Last Update Posted: May 30, 2017