Last updated: 11/04/2018 12:59:21

TREXIMA and RELPAX Gastric Scintigraphy inside and outside a migraine

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GSK study ID
TRX105848
See study documents
Clinicaltrials.gov ID
NCT00385008
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label, Single Dose, Parallel Group Study to Evaluate Absorption and Transit Characteristics of TREXIMA and RELPAX in Patients Inside and Outside of an Acute Migraine Attack.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Time to 10%, 50%, 90% and complete gastric empting of the radioactive markers representing sumatriptan, naproxen and eletriptan

Timeframe: Day 1 of each treatment administration (For 30 days)

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

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Mean AUC (0-inf) and AUC (0-2) for eletriptan

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Maximum Observed Drug Concentration (Cmax) for sumatriptan and naproxen

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Cmax for eletriptan

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Time of maximal drug concentration (tmax) for sumatriptan and naproxen

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Tmax for eletriptan

Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Time to complete dispersion of the sumatriptan and naproxen portions of the TREXIMA tablet and of the Relpax tablet

Timeframe: Day 1 of each treatment administered (For 30 days)

Time to first appearance of sumatriptan, naproxen and eletriptan at the proximal small intestine

Timeframe: Day 1 of each treatment administered (For 30 days)

Small intestine transit and residence (time to 50% through intestine) of the radioactive markers representing sumatriptan, naproxen and eletriptan

Timeframe: Day 1 of each treatment administered (For 30 days)

Secondary outcomes:

Number of participants with any adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to Day 30

Interventions:
  • Drug: Combination Product (sumatriptan succinate / naproxen sodium)
  • Drug: RELPAX(eletriptan) 40mg Tablet
    • Enrollment:
    20
    Primary completion date:
    2006-24-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastric Emptying and Absorption of a Sumatriptan with RT Technology 85mg and Naproxen Sodium 500mg Tablet. Cephalalgia 2007; Vol 27; 649.
    Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastroscintigraphic Evaluation of Gastric Emptying and Absorption of Another Conventionally Formulated Triptan. Cephalalgia 2007; Vol 27; 730.
    Kori S, Byrd SC, Doll WJ, Page RC, and Sandefer EP. Gastric Transit and Absorption of Sumatriptan and Naproxen from a Fixed Single-Tablet Sumatriptan RT Technology 85mg and Naproxen Sodium 500mg in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):751.
    Kori S, Doll WJ, Page RC, Byrd SC, Sandefer EP. Gastric Transit and Absorption of Eletriptan, another Conventionally Formulated Triptan, in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):752.
    Medical condition
    Migraine Disorders
    Product
    sumatriptan
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-24-11
    Actual study completion date
    2006-24-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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