Trial · NCT01332500
Treximet ™ Pharmacy Budget Impact Model Database Validation Study
NCT01332500, Completed, GlaxoSmithKline; results first posted 2011-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treximet ™ Pharmacy Budget Impact Model Database Validation Study. Trials, record NCT01332500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01332500
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treximet ™ Pharmacy Budget Impact Model Database Validation Study
- NCT number
- NCT01332500
- Status
- Completed
- Enrollment
- 61,737 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- Sumatriptan/Naproxen combination, other oral triptans
- First posted
- 2011-04-11
- Last updated
- 2017-05-30
- Results first posted
- 2011-04-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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). |
| Primary | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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. |
| Primary | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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. |
| Primary | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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). |
| Primary | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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. |
| Primary | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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. | tablets per participant | MEAN |
| PRIMARY | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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. | United States dollars | MEAN |
| PRIMARY | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis | 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) | 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. | United States dollars | MEAN |
| PRIMARY | Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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. | tablets per participant | MEAN |
| PRIMARY | Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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. | United States dollars | MEAN |
| PRIMARY | Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis | 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) | 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. | United States dollars | MEAN |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Sumatriptan/Naproxen Sodium | Triptans | 17.7 | Standard Deviation 16.3 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Oral Triptan | Triptans | 18.4 | Standard Deviation 18.2 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Sumatriptan/Naproxen Sodium | Non-steroidal anti-inflammatory drugs | 19.2 | Standard Deviation 57.1 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Oral Triptan | Non-steroidal anti-inflammatory drugs | 21.5 | Standard Deviation 64.9 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Sumatriptan/Naproxen Sodium | Opioids | 75.8 | Standard Deviation 219.0 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Oral Triptan | Opioids | 80.1 | Standard Deviation 235.8 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Sumatriptan/Naproxen Sodium | Ergots | 0.1 | Standard Deviation 3.6 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Oral Triptan | Ergots | 0.1 | Standard Deviation 2.4 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Sumatriptan/Naproxen Sodium | Other | 1.5 | Standard Deviation 17.0 | tablets per participant |
| Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis | Naïve - Oral Triptan | Other | 1.4 | Standard Deviation 13.9 | tablets per participant |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naïve - Sumatriptan/Naproxen Sodium | 13,257 | |
| Overall Study | STARTED | Naïve - Oral Triptan | 39,771 | |
| Overall Study | STARTED | Switch - Sumatriptan/Naproxen Sodium | 2,903 | |
| Overall Study | STARTED | Switch - Oral Triptan | 5,806 | |
| Overall Study | COMPLETED | Naïve - Sumatriptan/Naproxen Sodium | 13,257 | |
| Overall Study | COMPLETED | Naïve - Oral Triptan | 39,771 | |
| Overall Study | COMPLETED | Switch - Sumatriptan/Naproxen Sodium | 2,903 | |
| Overall Study | COMPLETED | Switch - Oral Triptan | 5,806 | |
| Overall Study | NOT COMPLETED | Naïve - Sumatriptan/Naproxen Sodium | 0 | |
| Overall Study | NOT COMPLETED | Naïve - Oral Triptan | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naïve - Sumatriptan/Naproxen Sodium | ||
| Total, all-cause mortality | Naïve - Oral Triptan | ||
| Total, all-cause mortality | Switch - Sumatriptan/Naproxen Sodium | ||
| Total, all-cause mortality | Switch - Oral Triptan | ||
| Total, other adverse events | Naïve - Sumatriptan/Naproxen Sodium | 0 | 0 |
| Total, other adverse events | Naïve - Oral Triptan | 0 | 0 |
| Total, other adverse events | Switch - Sumatriptan/Naproxen Sodium | 0 | 0 |
| Total, other adverse events | Switch - Oral Triptan | 0 | 0 |
| Total, serious adverse events | Naïve - Sumatriptan/Naproxen Sodium | 0 | 0 |
| Total, serious adverse events | Naïve - Oral Triptan | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01332500
GET https://conductscience.org/api/trials/v1/NCT01332500/results?page=2