Phase 3
N=20
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00385008 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan — 0.100; 0.130; 1.195; 1.300 hours (hr)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Combination Product (sumatriptan succinate / naproxen sodium) (Drug); RELPAX(eletriptan) 40mg Tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan |
0.100; 0.130; 1.195; 1.300; 0.400; 0.410 | — |
| PRIMARY Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen |
231.526; 165.707; 231.999; 158.036; 65.156; 54.884 | — |
| PRIMARY Mean AUC (0-inf) and AUC (0-2) for Eletriptan |
540.669; 570.860; 70.249; 78.092 | — |
| PRIMARY Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen |
49.900; 45.676; 46.34; 56.36 | — |
| PRIMARY Cmax for Eletriptan |
80.246; 91.323 | — |
| PRIMARY Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen |
2.000; 1.500; 4.50; 4.00 | — |
| PRIMARY Tmax for Eletriptan |
2.500; 2.000 | — |
| PRIMARY Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet |
0.050; 0.050; 1.125; 1.250; 0.600; 0.670 | — |
| PRIMARY Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine |
4.365; 4.350; 4.510; 4.350; 5.530; 5.810 | — |
| PRIMARY Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan |
2.895; 2.990; 2.550; 2.230; 4.335; 4.140 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) |
8; 3; 0; 0 | — |
Summary
An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
Eligibility Criteria
Inclusion Criteria
- Consented males and nonpregnant females using adequate contraception, between 18 and 55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects will be excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10 cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders, inflammatory bowel disease; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.
Data sourced from ClinicalTrials.gov (NCT00385008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.