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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01544114
First received: February 21, 2012
Last updated: August 11, 2014
Last verified: August 2014
  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 250/20
Drug: VIMOVO 375/20
Drug: VIMOVO 500/20
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:


Further study details as provided by Horizon Pharma, Inc.:

Primary Outcome Measures:
  • Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: For AEs: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and Month 6.5. For SAEs: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and Month 6.5. ] [ 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:
  • Pharmacokinetics (PK) in terms of characteristics of VIMOVO (naproxen / esomeprazole). [ Time Frame: Sparse PK sampling: Months 1 and 3. Frequent PK sampling: Month 1 only. ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIMOVO
VIMOVO (naproxen/esomeprazole) tablets
Drug: VIMOVO 250/20
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Other Name: 250 mg naproxen/20 mg esomeprazole
Drug: VIMOVO 375/20
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Other Name: 375 mg naproxen/20 mg esomeprazole
Drug: VIMOVO 500/20
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Other Name: 500 mg naproxen/20 mg 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72202
United States, California
Research Site
San Francisco, California, United States, 94143
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20010
United States, Florida
Research Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Research Site
Augusta, Georgia, United States, 30912
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68114
United States, New York
Research Site
Brooklyn, New York, United States, 11203
Research Site
New Hyde Park, New York, United States, 11040
Research Site
New York, New York, United States, 10021
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45229
Research Site
Cleveland, Ohio, United States, 44195
Research Site
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
Horizon Pharma, Inc.
Investigators
Study Director: Amy Y Grahn, MS Horizon Pharma
  More Information

No publications provided

Responsible Party: Horizon Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01544114     History of Changes
Other Study ID Numbers: D1120C00037
Study First Received: February 21, 2012
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Esomeprazole
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014