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View Clinical Trial (Medical Research Study)
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Migraine Study in Adolescent Patients - NCT00843024-12308 (Clinical Trial 271528)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy271528.aspx
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| City: |
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Schenectady |
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State:
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NY |
| Zip Code: |
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12308 |
| Conditions: |
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Migraine - Migraine Headache - Migraine With or Without Aura - Migraine, Acute |
| Purpose: |
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This study was designed to determine how well the combination medication, sumatriptan and
naproxen sodium, treats migraine headache in adolescents 12-17 years old
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| Study summary: |
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The purpose of this study is to determine whether the combination product, sumatriptan and
naproxen sodium, is effective compared to placebo in the treatment of acute migraine in
adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25
week period. |
| Criteria: |
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Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the
following criteria:
1. Subject is >/=12 years of age and >/=17 years of age at the Screening Visit.
2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history
of at least two, but no more than eight attacks per month, for the six months prior
to the Screening Visit is required. Attacks should last a minimum of three hours and
be associated with moderate-to-severe headache pain.
3. Subject is able to distinguish migraine from other headaches (i.e., tension-type
headaches).
4. Male or female subjects. Female subjects are eligible for participation in the study
if they are:
1. Females of non-childbearing potential; or
2. Females of childbearing potential, and who have a negative urine pregnancy test
at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly
effective methods for avoiding pregnancy
5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for
at least 2 months prior to screening.
6. Subject and subject's parent or legal guardian are able to read and write English or
Spanish.
7. Subject is able to read, comprehend, and complete subject diaries.
8. Subject's parent or legal guardian is willing and able to provide Informed Consent
prior to subject entry into the study.
9. Subject is willing and able to provide Informed Assent prior to entry into the study
(if required).
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Exclusion Criteria:
- Subjects meeting any of the following criteria must not be enrolled in the study:
1. Subject is < 74 pounds (33.3 kg).
2. Subject has ≥15 headache days per month in total (migraine, probable migraine,
or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic
migraine (ICHD-II 1.2.4), or secondary headaches.
3. Subject, in the investigator's opinion is likely to have unrecognized
cardiovascular or cerebrovascular disease.
4. Subject has uncontrolled hypertension at screening or is taking any
angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
5. 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.
6. Subject has evidence or history of any ischemic vascular diseases including:
ischemic heart disease, ischemic abdominal syndromes, peripheral vascular
disease, or signs/symptoms consistent with any of the above.
7. Subject has evidence or history of central nervous system pathology including
stroke and/or transient ischemic attacks (TIAs), 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.
8. Subject has a history of impaired hepatic or renal function that, in the
investigator's opinion, contraindicates participation in this study.
9. 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.
10. Subject has used an ergot medication in the previous three months for migraine
prophylaxis or is taking a medication that is not stabilized (i.e., change of
dose within the past 2 months) for either chronic or intermittent migraine
prophylaxis or for a co-morbid condition that is not stabilized.
11. Subject has a recent history of regular use of opioids or barbiturates for
treatment of their 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.
12. Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI),
including herbal preparations containing St. John's Wort (Hypericum perforatum),
anytime within the two weeks prior to screening through two weeks post
treatment.
13. Subject has a history of any bleeding disorder or is currently taking any
anti-coagulant or any antiplatelet agent.
14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration,
or perforation in the past six months, gastrointestinal bleeding in the past
year, or evidence or history of inflammatory bowel disease.
15. Subject is pregnant, actively trying to become pregnant, or breast feeding or
subject is not willing to have pregnancy test(s).
16. Subject tests positive for illicit substances on toxicology screen, or 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.
17. Subject has participated in any investigational drug trial within the previous 4
weeks or plans to participate in another study at any time during this study. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 2, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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