- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02287376
Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
July 22, 2017 updated by: Depomed
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:
- 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.
The secondary objectives are to determine:
- The safety and tolerability of Cambia from a single dose
- Three-month safety evaluation of Cambia in outpatient usage in this population
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States
-
-
New York
-
Amherst, New York, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diclofenac Potassium
Diclofenac Potassium for Oral Solution 50 mg
|
NSAID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
• Cmax: maximum concentration (ng/mL)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Pharmacokinetics Outcome (2 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)
|
• tmax: time to maximum concentration (min)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Pharmacokinetics Outcome (3 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)
|
• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Pharmacokinetics Outcome (4 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)
|
• t1/2: terminal elimination half-life (min)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Pharmacokinetics Outcome (5 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)
|
• 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)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Pharmacokinetics Outcome (6 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)
|
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)
|
6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Outcome (1 of 7)
Time Frame: 3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)
|
• Treatment emergent AEs (TEAEs)
|
3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)
|
Safety Outcome (2 of 7)
Time Frame: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
|
• Serious adverse events (SAEs)
|
3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
|
Safety Outcome (3 of 7)
Time Frame: 3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)
|
• Withdrawals due to AEs
|
3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)
|
Safety Outcome (4 of 7)
Time Frame: 3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
|
• Deaths
|
3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)
|
Safety Outcome (5.1 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in vital sign measurements: Temperature (degrees C).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (5.2 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in vital sign measurements: Heart Rate (beats/min).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (5.3 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (5.4 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (5.5 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.1 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.2 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.3 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.4 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.5 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Basophils (%).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.6 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Eosinophils (%).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.7 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Neutrophils (%).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.8 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.9 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Hematology - Monocytes (%).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.10 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.11 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.12 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.13 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.14 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.15 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.16 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.17 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.18 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.19 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.20 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - LDH (U/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.21 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.22 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.23 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Urinalysis - pH.
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (6.24 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
|
3 months (signed informed consent/assent to the final visit)
|
Safety Outcome (7 of 7)
Time Frame: 3 months (signed informed consent/assent to the final visit)
|
• Physical examination findings including abnormal clinically significant findings
|
3 months (signed informed consent/assent to the final visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 6, 2014
First Posted (Estimate)
November 10, 2014
Study Record Updates
Last Update Posted (Actual)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 22, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- 81-0076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Diclofenac Potassium for Oral Solution
-
University of StrathclydeUnknownOsteopenia of Prematurity | HypophosphataemiaUnited Kingdom
-
DepomedCompleted
-
Foresee Pharmaceuticals Co., Ltd.CompletedHealthy VolunteersAustralia
-
Scripps HealthDepomedUnknown
-
Hospital de Clinicas de Porto AlegreUnknown
-
PfizerCompletedFungal InfectionUnited Kingdom
-
Theravance BiopharmaGlaxoSmithKline; Hammersmith Medicines ResearchCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
Aga Khan UniversityUnknownAcute HypokalemiaPakistan
-
NorgineQuotient SciencesCompleted
-
Anthera PharmaceuticalsCompletedCystic Fibrosis | Exocrine Pancreatic InsufficiencyUnited States