Migraine DisordersPhase 1NCT00875784
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)
A Phase 1 study testing TREXIMA™, IMITREX® (4mg) and IMITREX® (6mg) in people with Migraine Disorders, run by GlaxoSmithKline at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- TREXIMA™, IMITREX® (4mg) and IMITREX® (6mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2008to 14 Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests.
- Female subjects of non-childbearing potential
- Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
- BMI: 20-30 kg/m2, inclusive.
- Subject is willing and able to provide written informed consent.
Who cannot join
- Subjects who suffer from migraine attacks.
- Subject has confirmed or suspected ischemic heart disease; angina pectoris, history of myocardial infarction, documented silent ischemia, Prinzmetal's angina-coronary vasospasm, signs, or symptoms consistent with any of the above.
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's syndrome.
- Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
- Subject has a history of congenital heart disease.
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- Subject has hypertension at screening.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
- Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- History of impaired hepatic or renal function.
- Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort.
- Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication.
- Note: Excluded from this list are: acetaminophen at doses of less than or equal to 2 grams per day and contraceptives.
- Subject has a hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
- Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
- Subject has a history of gastric bypass or stapling surgery.
- Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
- Subject has a history of inflammatory bowel disease.
- Treatment with an investigational drug within 30 preceding the first dose of study medication.
- Positive serum beta-human chorionic gonadotropin test -females.
- Pregnant, actively trying to become pregnant or breast-feeding.
- Subjects with a history of drug or alcohol abuse.
- History of regular alcohol consumption exceeding 7 drinks per week for females or 14 drinks per week for men within 6 months of screening.
- Positive urine drug screen including alcohol at screening.
- Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
- Subjects who smoke more than 10 cigarettes per day.
- History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 IMI
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.
Read the detailed description
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.
- Conditions
- Migraine Disorders
- Being tested
- TREXIMA™, IMITREX® (4mg), IMITREX® (6mg), IMITREX Tablet 100mg
- Keywords
- Sumatriptan exposure
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREXIMA™Drug
sumatriptan succinate / naproxen sodium tablet
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 100mgDrug
IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 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® Receives: Drug: TREXIMA™; Drug: IMITREX® (4mg) |
| TREXIMA tablet followed by IMITREX injection (6mg) | Experimental | TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® Receives: Drug: TREXIMA™; Drug: IMITREX® (6mg) |
| IMITREX tablet (100mg) | Active comparator | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet Receives: Drug: IMITREX Tablet 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: ten weeks
Secondary outcomes (1)
Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests.
Measured: ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study start6 May 2008
- Primary completion14 Jun 2008
- Study completion14 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875784
- Sponsor's protocol ID
- 103629
- Status last verified
- Aug 2017
- First submitted
- 26 Mar 2009
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 20637969
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 IMI
- ClinicalTrials.gov ID
- NCT00875784
- Acronym / sponsor ID
- 103629
- Conditions
- Migraine Disorders
- Keywords
- Sumatriptan exposure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 May 2008 (actual)
- Primary completion
- 14 Jun 2008 (actual)
- Study completion
- 14 Jun 2008 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TREXIMA tablet followed by IMITREX injection (4mg) | Experimental | Drug: TREXIMA™, Drug: IMITREX® (4mg)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 | Drug: TREXIMA™, Drug: IMITREX® (6mg)TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® |
| IMITREX tablet (100mg) | Active comparator | Drug: IMITREX Tablet 100mgIMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests.
- Female subjects of non-childbearing potential
- Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
- BMI: 20-30 kg/m2, inclusive.
- Subject is willing and able to provide written informed consent.
Key exclusion criteria (27 listed)
- Subjects who suffer from migraine attacks.
- Subject has confirmed or suspected ischemic heart disease; angina pectoris, history of myocardial infarction, documented silent ischemia, Prinzmetal's angina-coronary vasospasm, signs, or symptoms consistent with any of the above.
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's syndrome.
- Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREXIMA™sumatriptan succinate / naproxen sodium tablet | Drug | TREXIMA tablet followed by IMITREX injection (4mg), TREXIMA tablet followed by IMITREX injection (6mg) |
| IMITREX® (4mg)sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® | Drug | TREXIMA tablet followed by IMITREX injection (4mg) |
| IMITREX® (6mg)sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® | Drug | TREXIMA tablet followed by IMITREX injection (6mg) |
| IMITREX Tablet 100mgIMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet | Drug | IMITREX tablet (100mg) |
Primary outcome
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).
Time frame: ten weeks
1 secondary outcome
Incidence and severity of adverse events, blood pressure, pulse, ECGs and clinical laboratory tests.
Time frame: ten weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Derived from this study: PubMed 20637969Berges 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 103629 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TREXIMA™, IMITREX® (4mg) and IMITREX® (6mg) in people with Migraine Disorders, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: ten weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.