Migraine DisordersPhase 1NCT00989625
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
A Phase 1 study testing This is a pharmacokinetic study (Treximet) in people with Migraine Disorders, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. Read more about this study
- Who is it for?
- Ages 12 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- This is a pharmacokinetic study (Treximet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Nov 2008to 10 Sep 2009
- 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 12 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent Migraine Subjects
- Subject has history of migraine with or without aura.
- Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours.
- Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the screening visit.
- Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
- Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
Show all 23Show fewer
- All subjects
- Subject must fall between following age ranges:
- Adolescent subjects between 12 and 17 years old inclusive at the screening visit and 18 years at dosing.
- Adult healthy subjects between 18 to 55 years old inclusive at the screening visit.
- Subject BMI and weight must fall between the following:
- Adolescent subject body weight less than 33.4 kg and a healthy weight using age-based BMI range 5th-85th percentile (see Appendix 4).
- Adult healthy subject BMI within the range 18-32 kg/m2 inclusive
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. For younger adolescent migraine subjects, non-childbearing potential also defined as premenarchal is a young female who has not yet entered puberty as evidenced by lack of breast development of palpable glandular breast tissue. Females on hormone replacement therapy and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]
- Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects who are sexually active must agree to use contraception until 5 day after dosing.
- Subjects must be able to read and write English or Spanish and give written informed consent as follows:
- Adult: subject is willing and able to provide written informed consent
- Adolescent: subject is capable of giving written assent with an informed consent from their parents or legal guardian, which includes compliance with the requirements and restrictions listed in the consent form.
- Eligible subjects should meet the QT criteria as follows:
- Adolescent: QTcB or QTcF <450 msec; and without Bundle Branch Block
- Adult: QTcB or QTcF<450 msec; or QTc <480 msec in subjects with Bundle Branch Block.
Who cannot join
- Adolescent Migraineur Subjects
- Subject has ≥15 headache days per month in total, retinal, basilar or hemiplegic migraine or secondary headaches.
- Subject is experiencing a migraine attack or has experienced a migraine attack within 24 hours of dosing.
- All subjects:
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Show all 39Show fewer
- A positive test for HIV antibody.
- Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1)
- Subject has uncontrolled hypertension
- Adults: systolic >/=140 mmHg, diastolic >/=90mmHg
- Adolescent BP >/= 95 percentile adjusted for age, height and gender (Appendix 4).
- Subject has a history of congenital heart disease, 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 evidence or history of any ischemic vascular diseases including:ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks, epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function
- Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
- Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e., change of dose within the past month) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
- Subject has a recent history of regular use of opioids or barbiturates for treatment of his/her migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
- Subject has taken, or plans to take, a monoamine oxidase inhibitor, or herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
- Subject history of any bleeding disorder or is currently taking any anti-coagulant or any anti-platelet agent.
- Subject has evidence or history of any gastrointestinal surgery (other than appendectomy >/=6 months previously which is permitted) or GI ulceration or perforation or gastrointestinal bleeding or evidence or history of inflammatory bowel disease.
- Subject is pregnant, actively trying to become pregnant, or breast feeding or subject not willing to have pregnancy test performed at each study visit.
- Sexually active female subjects using inadequate contraceptive measures (i.e., a method with a failure rate >1%)
- Subject has evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
- History of regular alcohol consumption within 6 months of the study defined as:
- Adults: An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- Adolescents: Adult limits may be applicable for adolescents >16 years of age. For adolescents in younger group (< 16 years of age) that enrolment will be at the discretion of the investigator, but drinking should be no more than 50% of the allowance for adults (e.g. children of 14 are drinking no more than 7 drinks (70 g week, [Tur, 2003]).
- Subject has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.
- An adult subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). An adolescent subject should not have received an investigational product within the previous 6 months.
- Subject exposure to chemical entities defined as:
- Adult subject exposed to more than four new chemical entity within 12 months prior to the first dosing day.
- Adolescent subject exposed to more than 1 new chemical entities within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Subjects would have made a total donation of blood or blood products in excess of the following:
- 500 mL within a 56 day period before screening for Healthy adult subjects
- 10mL/kg within a 56 day period before screening for adolescents
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subjects who are kept due to regulatory or juridical order in an institution.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Memphis, Tennessee, 38105
GSK Investigational Site
Wichita, Kansas, 67207
About this study
Official title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses.
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.
Read the detailed description
This will be an open label, single dose, randomised, parallel group study. Approximately 27 adolescent patients with migraine and 27 healthy volunteer (HV) adult subjects will be enrolled so that a total of 24 evaluable subjects complete in each group. The treatment procedures for these two groups are almost identical but some flexibility has been allowed for the timing of some of the PK samples in adolescents. All subjects will be required to attend a screening visit within 28 days prior to the first dose of study medication. Each subject will participate in one dosing session with one of the 3 doses of sumatriptan/ naproxen sodium. Sequential PK samples will be collected through 48 hours after dosing and the PK parameters will be compared between these two groups and between doses.
- Conditions
- Migraine Disorders
- Being tested
- This is a pharmacokinetic study (Treximet)
- Keywords
- migraine, single dose, healthy volunteer, adolescence, pharmacokinetics
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a pharmacokinetic study (Treximet)Drug
This is a pharmacokinetic study to collect PK samples from subject after single dose.
This is a pharmacokinetic study (Treximet)Drug
This is a pharmacokinetic study to collect PK samples from subject after single dose.
This is a pharmacokinetic study (Treximet)Drug
This is a pharmacokinetic study to collect PK samples from subject after single dose.
| Study group | Role | What they receive |
|---|---|---|
| 10mg Sumatriptan/60mg Naproxen | Active comparator | There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. Receives: Drug: This is a pharmacokinetic study (Treximet) |
| 30mg Sumatriptan/180mg Naproxen | Active comparator | There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. Receives: Drug: This is a pharmacokinetic study (Treximet) |
| 85mg Sumatriptan/500mg Naproxen | Active comparator | There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. Receives: Drug: This is a pharmacokinetic study (Treximet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pharmacokinetics of naproxen sodium and sumatriptan following the administration of the combination tablet at 3 doses (10mg sumatriptan/60mg naproxen, 30mg sumatriptan/180mg naproxen, 85mg sumatriptan/500mg naproxen) from 0 to 48 hours.
Measured: Derived pharmacokinetic parameters including AUC(0-2), AUC(0-Inf), AUC(0-t) and Cmax for sumatriptan at each dose. Derived pharmacokinetic parameters including AUC(0-Inf), AUC(0-t) and Cmax, for naproxen at each dose from 0 to 48 hours.
Secondary outcomes (2)
To investigate the safety and tolerability of the combination tablet at 3 doses in adolescent migraine subjects and healthy adult subjects over 2 weeks.
Measured: Derived PK parameters including tmax, t½, and Cl/F (0-48 hours) for sumatriptan at each dose. Derived pharmacokinetic parameters including tmax and t½ and Cl/F for naproxen sodium at each dose. Reported AEs, BP, heart rate, 12-Lead (0-48 hours).
Report adverse events, blood pressure, heart rate and 12-Lead ECG over 2 weeks.
Measured: These will be measured after dosing within 48 hours and 7-14 days after dosing period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study start4 Nov 2008
- Primary completion10 Sep 2009
- Study completion10 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00989625
- Sponsor's protocol ID
- 108504
- Status last verified
- Jun 2017
- First submitted
- 20 Mar 2009
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses.
- ClinicalTrials.gov ID
- NCT00989625
- Acronym / sponsor ID
- 108504
- Conditions
- Migraine Disorders
- Keywords
- migraine, single dose, healthy volunteer, adolescence, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2008 (actual)
- Primary completion
- 10 Sep 2009 (actual)
- Study completion
- 10 Sep 2009 (actual)
- First posted
- 5 Oct 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 is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.
Detailed description
This will be an open label, single dose, randomised, parallel group study. Approximately 27 adolescent patients with migraine and 27 healthy volunteer (HV) adult subjects will be enrolled so that a total of 24 evaluable subjects complete in each group. The treatment procedures for these two groups are almost identical but some flexibility has been allowed for the timing of some of the PK samples in adolescents. All subjects will be required to attend a screening visit within 28 days prior to the first dose of study medication. Each subject will participate in one dosing session with one of the 3 doses of sumatriptan/ naproxen sodium. Sequential PK samples will be collected through 48 hours after dosing and the PK parameters will be compared between these two groups and between doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10mg Sumatriptan/60mg Naproxen | Active comparator | Drug: This is a pharmacokinetic study (Treximet)There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. |
| 30mg Sumatriptan/180mg Naproxen | Active comparator | Drug: This is a pharmacokinetic study (Treximet)There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. |
| 85mg Sumatriptan/500mg Naproxen | Active comparator | Drug: This is a pharmacokinetic study (Treximet)There is only one dose (one tablet) for each subject. Subject to be randomized to either: 10mg Sumatriptan/60 mg Naproxen or 30mg Sumatriptan/180mg Naproxen or 85mg Sumatriptan/500mg Naproxen. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (23 listed)
- Adolescent Migraine Subjects
- Subject has history of migraine with or without aura.
- Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours.
- Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the screening visit.
- Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
Key exclusion criteria (39 listed)
- Adolescent Migraineur Subjects
- Subject has ≥15 headache days per month in total, retinal, basilar or hemiplegic migraine or secondary headaches.
- Subject is experiencing a migraine attack or has experienced a migraine attack within 24 hours of dosing.
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
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 |
|---|---|---|
| This is a pharmacokinetic study (Treximet)This is a pharmacokinetic study to collect PK samples from subject after single dose. | Drug | 10mg Sumatriptan/60mg Naproxen |
| This is a pharmacokinetic study (Treximet)This is a pharmacokinetic study to collect PK samples from subject after single dose. | Drug | 30mg Sumatriptan/180mg Naproxen |
| This is a pharmacokinetic study (Treximet)This is a pharmacokinetic study to collect PK samples from subject after single dose. | Drug | 85mg Sumatriptan/500mg Naproxen |
Primary outcome
To compare the pharmacokinetics of naproxen sodium and sumatriptan following the administration of the combination tablet at 3 doses (10mg sumatriptan/60mg naproxen, 30mg sumatriptan/180mg naproxen, 85mg sumatriptan/500mg naproxen) from 0 to 48 hours.
Time frame: Derived pharmacokinetic parameters including AUC(0-2), AUC(0-Inf), AUC(0-t) and Cmax for sumatriptan at each dose. Derived pharmacokinetic parameters including AUC(0-Inf), AUC(0-t) and Cmax, for naproxen at each dose from 0 to 48 hours.
2 secondary outcomes
To investigate the safety and tolerability of the combination tablet at 3 doses in adolescent migraine subjects and healthy adult subjects over 2 weeks.
Time frame: Derived PK parameters including tmax, t½, and Cl/F (0-48 hours) for sumatriptan at each dose. Derived pharmacokinetic parameters including tmax and t½ and Cl/F for naproxen sodium at each dose. Reported AEs, BP, heart rate, 12-Lead (0-48 hours).
Report adverse events, blood pressure, heart rate and 12-Lead ECG over 2 weeks.
Time frame: These will be measured after dosing within 48 hours and 7-14 days after dosing period.
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 19 Jun 2017.
- 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 108504 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.
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing This is a pharmacokinetic study (Treximet) in people with Migraine Disorders, run by GlaxoSmithKline at 3 sites 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 23 inclusion and 39 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
To compare the pharmacokinetics of naproxen sodium and sumatriptan following the administration of the combination tablet at 3 doses (10mg sumatriptan/60mg naproxen, 30mg sumatriptan/180mg naproxen, 85mg sumatriptan/500mg naproxen) from 0 to 48 hours. (time frame: Derived pharmacokinetic parameters including AUC(0-2), AUC(0-Inf), AUC(0-t) and Cmax for sumatriptan at each dose. Derived pharmacokinetic parameters including AUC(0-Inf), AUC(0-t) and Cmax, for naproxen at each dose from 0 to 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2017.