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This study will evaluate the exposure of sumatriptan after administration of TREXIMA (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or 6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX 100mg tablet 2 hours later.
An open-label, randomized, 3-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® and a TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® compared with an IMITREX Tablet 100mg followed by an IMITREX Tablet 100mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREXIMA tablet followed by IMITREX injection (4mg) | Experimental | TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® |
|
| TREXIMA tablet followed by IMITREX injection (6mg) | Experimental | TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® |
|
| IMITREX tablet (100mg) | Active Comparator | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREXIMA™ | Drug | sumatriptan succinate / naproxen sodium tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) after the second dose and total exposure (measured by AUC(0-∞) calculated as pooled exposure from both the initial and second dose). | ten weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests. | ten weeks |
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Inclusion Criteria:
Exclusion Criteria:
Note: Excluded from this list are: acetaminophen at doses of less than or equal to 2 grams per day and contraceptives.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tacoma | Washington | 98418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20637969 | Derived | Berges A, Walls C, Lener SE, McDonald SA. Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-label, three-period crossover study in healthy volunteers. Clin Ther. 2010 Jun;32(6):1165-77. doi: 10.1016/j.clinthera.2010.06.014. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 103629 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| IMITREX® (4mg) | Drug | sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® |
|
| IMITREX® (6mg) | Drug | sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® |
|
| IMITREX Tablet 100mg | Drug | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
|
| Results for study 103629 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103629 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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