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|NCT02287376 : Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds|
|Ages||Min: 12 Years Max: 17 Years|
1. Subject is ?12 and ?17 years of age at screening.
2. Subject diagnosed with episodic migraine with or without aura for at least 3 months
(migraine defined based on the International classification of headache disorders-II
1.2.1 or 1.1).
3. Subject has 14 or fewer headache days per month.
4. Subject receiving prophylactic treatment for migraine may be included.
5. If female, is not of childbearing potential (defined as premenarchal) or if of
childbearing potential must have a negative serum pregnancy test at screening and a
negative urine pregnancy test on Study Day 1, if the Screening visit and Day 1 are
not on the same day, and must use medically acceptable methods of birth control as
listed below and agrees to continue its use throughout the study:1) hormonal methods
(e.g., oral, implantable, injectable, or transdermal contraceptives for a minimum of
1 full menstrual cycle before study drug administration), 2) Total abstinence from
sexual intercourse since the last menses before study drug administration, 3)
intrauterine device, 4) double-barrier method (e.g., condoms, sponge, diaphragm, or
vaginal ring with spermicidal jellies or cream).
6. Subject's legally authorized representative (e.g., parent, guardian) must voluntarily
sign and date an informed consent form (ICF) that is approved by an Institutional
Review Board (IRB), and the subject must sign an assent (if appropriate), before the
commencement of any study assessment.
7. Subject's legally authorized representative (e.g., parent, guardian) and subject (if
appropriate), is able to read and understand the study procedures and requirements
and adhere to the protocol requirements and procedures.
1. Subject has a known history of allergic reaction, hypersensitivity, or clinically
significant intolerance to diclofenac, aspirin, or any nonsteroidal anti inflammatory
drugs (NSAIDs); history of NSAID induced bronchospasm (subjects with the triad of
asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and
should be considered carefully); or hypersensitivity, allergy, or significant
reaction to the non-active ingredients of the study medication.
2. Subject is pregnant or lactating or considered at risk of pregnancy.
3. Subject has been under an inconsistent dosing regimen of prophylactic treatment for
4. Subject has headache symptoms likely due to, or aggravated by, traumatic injury to
the head or neck region, such as whiplash, within the last six months;
5. Subject has or is suspected of having a secondary headache.
6. Subject has significant abnormal findings during the neurological exam at screening.
7. Subject has a history of any GI event (e.g., perforation, obstruction, bleed) before
Screening that, in the opinion of the investigator, would make the subject unsuitable
for study participation.
8. Subject is receiving any medication that, in the opinion of the investigator, may
cause a clinically significant condition when used concomitantly with diclofenac
(e.g., aspirin, anticoagulants, ACE inhibitors, methotrexate, cyclosporine,
9. Subject is and has been receiving a medication that is known to strongly inhibit
and/or induce cytochrome P450 2C9 such that it might unpredictably affect the
pharmacokinetics of diclofenac (e.g., fluconazole, amiodarone, oxandrolone,
sulfipyrazone as inhibitors and rifampin as an inducer).
10. Subject has any condition or any laboratory abnormality that would, in the opinion of
the investigator, contraindicate study participation.
11. Subject has impaired liver function (e.g., alanine aminotransferase [ALT] ? 3 times
the upper limit of normal [ULN] or bilirubin ? 3 times ULN), known active hepatic
disease (e.g., hepatitis), or evidence of clinically significant liver disease or
other condition affecting the liver that may suggest the potential for an increased
susceptibility to hepatic toxicity with oral diclofenac exposure.
12. Subject has any history of renal disease that, in the opinion of the investigator,
would contraindicate study participation; or subject has significantly impaired renal
function as evidenced by an estimated GFR of ?60 ml/min/1.73m2.
13. Subject is considered by the investigator, for any reason (including, but not limited
to the risks described as precautions, warnings, and contraindications in the
Prescribing Information for Cambia), to be an unsuitable candidate to receive the
14. Subject has a history of laboratory test results obtained within 6 months before the
Screening visit that show the presence of HIV, hepatitis B surface antigen, hepatitis
C antibody, or active hepatitis A immunoglobulin M.
15. Subject is currently receiving any medication that is contraindicated for use
concomitantly with diclofenac (refer to the products' professional labeling) or the
subject has not undergone a washout period of at least 5-6 half-lives of PK or PD,
whichever is longer, for these medications.
16. Subject has a known or suspected history of alcohol use and or drug/ substance abuse
or misuse within 2 years before Screening; or evidence of tolerance or physical
dependence before study medication administration.
17. Subject has a documented history of a medical condition that, in the opinion of the
investigator, would compromise the subject's ability to absorb, metabolize, or
excrete diclofenac, including (but not limited to) intractable nausea and/or vomiting
and/or severe GI narrowing (pathologic or iatrogenic).
18. Subject has received any investigational product or device within 30 days before the
Screening, or is scheduled to receive an investigational device or another
investigational drug (other than Cambia) during the course of this study.
19. Subject is a relative of a member of the study site staff or Sponsor directly
involved in this study.
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