A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Study with completed results acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Research Site
Little Rock, Arkansas, United States
Research Site
San Francisco, California, United States
Research Site
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.
Time frame: SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.
Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Absorption Rate Constant (Ka)
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Volume of Distribution (V/F)
Time frame: pre-dose, and up to 3 hours post-dose
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Aurora, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Omaha, Nebraska, United States
Research Site
Brooklyn, New York, United States
Research Site
New Hyde Park, New York, United States
...and 7 more locations
PK of Naproxen: Trough Plasma Concentrations
Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.
Time frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose