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MigrainePhase 4NCT02287376

Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds

A Phase 4 study testing Diclofenac Potassium for Oral Solution in people with Migraine, run by Depomed at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study Objectives: 1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without aura. 2. The secondary objectives are to determine: 1. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Migraine
What is being tested?
Diclofenac Potassium for Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
Jan 2015to Feb 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subject is ≥12 and ≤17 years of age at screening.
  • 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).
  • Subject has 14 or fewer headache days per month.
  • Subject receiving prophylactic treatment for migraine may be included.
  • 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).
  • 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.
  • 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.

Who cannot join

  • 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.
  • Subject is pregnant or lactating or considered at risk of pregnancy.
  • Subject has been under an inconsistent dosing regimen of prophylactic treatment for migraine.
  • 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;
  • Subject has or is suspected of having a secondary headache.
  • Subject has significant abnormal findings during the neurological exam at screening.
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  • 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.
  • 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, furosemide, lithium).
  • 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).
  • Subject has any condition or any laboratory abnormality that would, in the opinion of the investigator, contraindicate study participation.
  • 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.
  • 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.
  • 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 study medication.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • Subject is a relative of a member of the study site staff or Sponsor directly involved in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Amherst, New York

  • Study site

    Tampa, Florida

Other trials in United States

About this study

Official title: A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Cambia® (Diclofenac Potassium for Oral Solution) for the Acute Treatment of Migraine Attacks With or Without Aura in Pediatric Subjects (Ages 12-17 Years)

Study Objectives:

  1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without aura.
  2. The secondary objectives are to determine:
  3. The safety and tolerability of Cambia from a single dose
  4. Three-month safety evaluation of Cambia in outpatient usage in this population
Conditions
Migraine
Being tested
Diclofenac Potassium for Oral Solution
Keywords
Migraine with and without aura
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diclofenac Potassium for Oral SolutionDrug

    Also called Cambia

    NSAID

Study groups in NCT02287376
Study groupRoleWhat they receive
Diclofenac PotassiumExperimentalDiclofenac Potassium for Oral Solution 50 mg
Receives: Drug: Diclofenac Potassium for Oral Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics Outcome (1 of 6)

    • Cmax: maximum concentration (ng/mL)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

  2. Pharmacokinetics Outcome (2 of 6)

    • tmax: time to maximum concentration (min)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

  3. Pharmacokinetics Outcome (3 of 6)

    • λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

  4. Pharmacokinetics Outcome (4 of 6)

    • t1/2: terminal elimination half-life (min)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

  5. Pharmacokinetics Outcome (5 of 6)

    • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min*ng/mL)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

  6. Pharmacokinetics Outcome (6 of 6)

    • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)

    Measured: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)

Secondary outcomes (34)

  1. Safety Outcome (1 of 7)

    • Treatment emergent AEs (TEAEs)

    Measured: 3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)

  2. Safety Outcome (2 of 7)

    • Serious adverse events (SAEs)

    Measured: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)

  3. Safety Outcome (3 of 7)

    • Withdrawals due to AEs

    Measured: 3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)

  4. Safety Outcome (4 of 7)

    • Deaths

    Measured: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)

  5. Safety Outcome (5.1 of 7)

    • Changes in vital sign measurements: Temperature (degrees C).

    Measured: 3 months (signed informed consent/assent to the final visit)

  6. Safety Outcome (5.2 of 7)

    • Changes in vital sign measurements: Heart Rate (beats/min).

    Measured: 3 months (signed informed consent/assent to the final visit)

  7. Safety Outcome (5.3 of 7)

    • Changes in vital sign measurements: Respiratory Rate (breaths/min).

    Measured: 3 months (signed informed consent/assent to the final visit)

  8. Safety Outcome (5.4 of 7)

    • Changes in vital sign measurements: Systolic Blood Pressure (mmHg).

    Measured: 3 months (signed informed consent/assent to the final visit)

  9. Safety Outcome (5.5 of 7)

    • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).

    Measured: 3 months (signed informed consent/assent to the final visit)

  10. Safety Outcome (6.1 of 7)

    • Changes in clinical laboratory results: Hematology - Hematocrit (L/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  11. Safety Outcome (6.2 of 7)

    • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  12. Safety Outcome (6.3 of 7)

    • Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  13. Safety Outcome (6.4 of 7)

    • Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  14. Safety Outcome (6.5 of 7)

    • Changes in clinical laboratory results: Hematology - Basophils (%).

    Measured: 3 months (signed informed consent/assent to the final visit)

  15. Safety Outcome (6.6 of 7)

    • Changes in clinical laboratory results: Hematology - Eosinophils (%).

    Measured: 3 months (signed informed consent/assent to the final visit)

  16. Safety Outcome (6.7 of 7)

    • Changes in clinical laboratory results: Hematology - Neutrophils (%).

    Measured: 3 months (signed informed consent/assent to the final visit)

  17. Safety Outcome (6.8 of 7)

    • Changes in clinical laboratory results: Hematology - Lymphocytes (%).

    Measured: 3 months (signed informed consent/assent to the final visit)

  18. Safety Outcome (6.9 of 7)

    • Changes in clinical laboratory results: Hematology - Monocytes (%).

    Measured: 3 months (signed informed consent/assent to the final visit)

  19. Safety Outcome (6.10 of 7)

    • Changes in clinical laboratory results: Chemistry - Albumin (g/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  20. Safety Outcome (6.11 of 7)

    • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  21. Safety Outcome (6.12 of 7)

    • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  22. Safety Outcome (6.13 of 7)

    • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  23. Safety Outcome (6.14 of 7)

    • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  24. Safety Outcome (6.15 of 7)

    • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  25. Safety Outcome (6.16 of 7)

    • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  26. Safety Outcome (6.17 of 7)

    • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  27. Safety Outcome (6.18 of 7)

    • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  28. Safety Outcome (6.19 of 7)

    • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  29. Safety Outcome (6.20 of 7)

    • Changes in clinical laboratory results: Chemistry - LDH (U/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  30. Safety Outcome (6.21 of 7)

    • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  31. Safety Outcome (6.22 of 7)

    • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).

    Measured: 3 months (signed informed consent/assent to the final visit)

  32. Safety Outcome (6.23 of 7)

    • Changes in clinical laboratory results: Urinalysis - pH.

    Measured: 3 months (signed informed consent/assent to the final visit)

  33. Safety Outcome (6.24 of 7)

    • Changes in clinical laboratory results: Urinalysis - Specific Gravity.

    Measured: 3 months (signed informed consent/assent to the final visit)

  34. Safety Outcome (7 of 7)

    • Physical examination findings including abnormal clinically significant findings

    Measured: 3 months (signed informed consent/assent to the final visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02287376
Sponsor's protocol ID
81-0076
Status last verified
Jul 2017
First submitted
5 Nov 2014
Last updated
25 Jul 2017

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diclofenac Potassium for Oral Solution in people with Migraine, run by Depomed at 2 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 7 inclusion and 19 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetics Outcome (1 of 6) (time frame: 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)). The study lists 6 primary outcomes in all. 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 NCT02287376.

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 25 Jul 2017.

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