A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA) - Full Text View

Purpose

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

Condition	Intervention	Phase
Juvenile Idiopathic Arthritis (JIA)	Drug: VIMOVO	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Iron Juvenile Rheumatoid Arthritis

Drug Information available for: Naproxen Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Incidence of severity of AEs and SAEs. [ Time Frame: Baseline. ] [ Designated as safety issue: Yes ]
Incidence of severity of AEs and SAEs. [ Time Frame: Month 1. ] [ Designated as safety issue: Yes ]
Incidence of severity of AEs and SAEs. [ Time Frame: Month 3. ] [ Designated as safety issue: Yes ]
Incidence of severity of AEs and SAEs. [ Time Frame: Month 6. ] [ Designated as safety issue: Yes ]
Change in serum iron/total iron binding capacity (serum iron/TIBC), Vitamin B12, and magnesium. [ Time Frame: Will be assessed at baseline and Month 6 or at the early termination (ET) visit. ] [ Designated as safety issue: Yes ]
Change from baseline in vital signs, physical examination results and clinical laboratory tests. [ Time Frame: Baseline, Month 1, Month 3 and Month 6. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic (PK) in terms of characteristics of VIMOVO (naproxen / esomeprazole). [ Time Frame: Month 1 and 3. ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vimovo	Drug: VIMOVO 250 mg naproxen/20 mg esomeprazole magnesium oral tablet Drug: VIMOVO 375 mg naproxen/20 mg esomeprazole magnesium oral tablet Drug: VIMOVO 500 mg naproxen/20 mg esomeprazole magnesium oral tablet

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

Ages Eligible for Study:	12 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544114

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: Quintiles Worldwide		clinical.studiesns@quintiles.com

Locations

United States, Arkansas
Research Site	Not yet recruiting
Little Rock, Arkansas, United States
United States, Florida
Research Site	Not yet recruiting
West Palm Beach, Florida, United States
United States, New Jersey
Research Site	Not yet recruiting
Livingston, New Jersey, United States
United States, New York
Research Site	Not yet recruiting
Brooklyn, New York, United States
United States, North Carolina
Research Site	Not yet recruiting
Morrisville, North Carolina, United States
United States, Ohio
Research Site	Not yet recruiting
Cleveland, Ohio, United States
Research Site	Recruiting
Toledo, Ohio, United States
United States, Virginia
Research Site	Not yet recruiting
Fairfax, Virginia, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Stephen J Kanes

AstraZeneca R&D Wilmington

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01544114 History of Changes
Other Study ID Numbers:	D1120C00037
Study First Received:	February 21, 2012
Last Updated:	March 21, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013