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

February 21, 2012
August 11, 2014
April 2012
March 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence of severity of AEs and SAEs. [ Time Frame: Month 1. ] [ 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 ]
  • 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 3. ] [ Designated as safety issue: Yes ]
  • Incidence of severity of AEs and SAEs. [ Time Frame: Month 6. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01544114 on ClinicalTrials.gov Archive Site
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 ]
Pharmacokinetic (PK) in terms of characteristics of VIMOVO (naproxen / esomeprazole). [ Time Frame: Month 1 and 3. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
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)

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

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)

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis (JIA)
  • 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
Experimental: VIMOVO
VIMOVO (naproxen/esomeprazole) tablets
Interventions:
  • Drug: VIMOVO 250/20
  • Drug: VIMOVO 375/20
  • Drug: VIMOVO 500/20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
12 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544114
D1120C00037
No
Horizon Pharma, Inc.
Horizon Pharma, Inc.
Not Provided
Study Director: Amy Y Grahn, MS Horizon Pharma
Horizon Pharma, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP