Pharmacokinetics & Safety of Cambia® in Migraine With or... | NCT02287376

NCT02287376

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Diclofenac Potassium	Experimental	Diclofenac Potassium for Oral Solution 50 mg	Drug: Diclofenac Potassium for Oral Solution

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac Potassium for Oral Solution	Drug	NSAID	Diclofenac Potassium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics Outcome (1 of 6)	• 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)	• 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)	• 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)	• 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)	• 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)	• 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 Outcomes

Measure	Description	Time Frame
Safety Outcome (1 of 7)	• 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)

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

ID	Title	Description
FG000	Cambia®	Diclofenac Potassium for Oral Solution (NSAID), 50 mg

Baseline Characteristics Module

ID	Title	Description
BG000	Cambia®	Diclofenac Potassium for Oral Solution (NSAID), 50 mg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pharmacokinetics Outcome (1 of 6)

• Cmax: maximum concentration (ng/mL)

The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.

Posted

Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Cambia®	Diclofenac Potassium for Oral Solution (NSAID), 50 mg

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cambia®	Diclofenac Potassium for Oral Solution (NSAID), 50 mg

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Clinical Operations	Depomed	510-744-8000		clinicaltrials@depomed.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D008881	Migraine Disorders

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Intervention Browse Module

ID	Term
D004008	Diclofenac
D012996	Solutions

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Masking Info

• Serious adverse events (SAEs)

EG0001 affected25 at risk

Title	Measurements
	OG000-3.1± 14.27

Title	Measurements
	OG000-1.7± 9.62

Title	Measurements
	OG0000.020± 0.0190

Title	Measurements
	OG0004.720± 5.4430

Title	Measurements
	OG0003.400± 3.0277

Title	Measurements
	OG0004.800± 11.4054

Title	Measurements
	OG0000.400± 2.0817

Title	Measurements
	OG0000.800± 2.6615

Title	Measurements
	OG0000.520± 2.7099

Title	Measurements
	OG0001.163± 3.9107

Title	Measurements
	OG0000.081± 1.0515

Title	Measurements
	OG000-0.275± 0.9215

Title	Measurements
	OG0000.096± 0.3007

Title	Measurements
	OG0000.080± 0.8977

Facility	Status	City	State	ZIP	Country	Contacts
		Tampa	Florida		United States