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A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

Information source: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Idiopathic Arthritis (JIA)

Intervention: VIMOVO 250/20 (Drug); VIMOVO 375/20 (Drug); VIMOVO 500/20 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Horizon Pharma Ireland, Ltd., Dublin Ireland

Official(s) and/or principal investigator(s):
Amy Y Grahn, MS, Study Director, Affiliation: Horizon Pharma

Summary

A 6 month study of VIMOVO in adolescents aged 12-16 years with juvenile idiopathic Arthritis (JIA)

Clinical Details

Official title: A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

Change in serum iron/total iron binding capacity (serum iron/TIBC), Vitamin B12, and magnesium.

Change from baseline in vital signs, physical examination results, and clinical laboratory tests.

Secondary outcome: Pharmacokinetics (PK) in terms of characteristics of VIMOVO (naproxen / esomeprazole).

Detailed description: A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, with Juvenile Idiopathic Arthritis (JIA)

Eligibility

Minimum age: 12 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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 ILAR JIA subtypes: oligoarthritis,

polyarthritis (both 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.

Locations and Contacts

Research Site, Little Rock, Arkansas 72202, United States

Research Site, San Francisco, California 94143, United States

Research Site, Aurora, Colorado 80045, United States

Research Site, Washington, District of Columbia 20010, United States

Research Site, West Palm Beach, Florida 33407, United States

Research Site, Augusta, Georgia 30912, United States

Research Site, Chicago, Illinois 60637, United States

Research Site, Omaha, Nebraska 68114, United States

Research Site, Brooklyn, New York 11203, United States

Research Site, New Hyde Park, New York 11040, United States

Research Site, New York, New York 10021, United States

Research Site, Cincinnati, Ohio 45229, United States

Research Site, Cleveland, Ohio 44195, United States

Research Site, Toledo, Ohio 43623, United States

Research Site, Philadelphia, Pennsylvania 19134, United States

Research Site, Memphis, Tennessee 38119, United States

Research Site, Fairfax, Virginia 22030, United States

Additional Information

Starting date: April 2012
Last updated: April 8, 2015

Page last updated: August 23, 2015

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