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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01544114
Other study ID # D1120C00037
Secondary ID
Status Completed
Phase Phase 4
First received February 21, 2012
Last updated September 7, 2017
Start date April 2012
Est. completion date February 2015

Study information

Verified date September 2017
Source Horizon Pharma Ireland, Ltd., Dublin Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria:

- Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.

- Male and female adolescents aged 12 to 16 years at the time of enrollment.

- Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor [RF]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis.

- Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO.

- Body weight > 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.

Exclusion Criteria:

- In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.

- Currently taking (ie, within 4 weeks prior to start of drug) naproxen > 20 mg/kg/day or > 1000 mg total daily dose.

- Hemoglobin = 8.5 g/dL.

- Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.

- Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VIMOVO 250/20
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 375/20
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 500/20
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Locations

Country Name City State
United States Research Site Augusta Georgia
United States Research Site Aurora Colorado
United States Research Site Brooklyn New York
United States Research Site Chicago Illinois
United States Research Site Cincinnati Ohio
United States Research Site Cleveland Ohio
United States Research Site Fairfax Virginia
United States Research Site Little Rock Arkansas
United States Research Site Memphis Tennessee
United States Research Site New Hyde Park New York
United States Research Site New York New York
United States Research Site Omaha Nebraska
United States Research Site Philadelphia Pennsylvania
United States Research Site San Francisco California
United States Research Site Toledo Ohio
United States Research Site Washington, D.C. District of Columbia
United States Research Site West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Secondary Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) pre-dose, and up to 3 hours post-dose
Secondary PK of Esomeprazole: Oral Plasma Clearance (CL/F) pre-dose, and up to 3 hours post-dose
Secondary PK of Esomeprazole: Absorption Rate Constant (Ka) pre-dose, and up to 3 hours post-dose
Secondary PK of Esomeprazole: Oral Volume of Distribution (V/F) pre-dose, and up to 3 hours post-dose
Secondary 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. Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
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Active, not recruiting NCT03725007 - A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis Phase 1
Recruiting NCT03245801 - CAPRI National Juvenile Idiopathic Arthritis Registry
Completed NCT05000216 - COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders Phase 2

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