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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544114
First Posted: March 5, 2012
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
February 21, 2012
March 5, 2012
August 4, 2017
October 4, 2017
October 4, 2017
April 2012
February 2015   (Final data collection date for primary outcome measure)
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug [ Time Frame: 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. ]
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.
  • Incidence of severity of AEs and SAEs. [ Time Frame: Baseline. ]
  • Incidence of severity of AEs and SAEs. [ Time Frame: Month 1. ]
  • Incidence of severity of AEs and SAEs. [ Time Frame: Month 3. ]
  • Incidence of severity of AEs and SAEs. [ Time Frame: Month 6. ]
  • 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. ]
  • Change from baseline in vital signs, physical examination results and clinical laboratory tests. [ Time Frame: Baseline, Month 1, Month 3 and Month 6. ]
Complete list of historical versions of study NCT01544114 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) [ Time Frame: pre-dose, and up to 3 hours post-dose ]
  • PK of Esomeprazole: Oral Plasma Clearance (CL/F) [ Time Frame: pre-dose, and up to 3 hours post-dose ]
  • PK of Esomeprazole: Absorption Rate Constant (Ka) [ Time Frame: pre-dose, and up to 3 hours post-dose ]
  • PK of Esomeprazole: Oral Volume of Distribution (V/F) [ Time Frame: pre-dose, and up to 3 hours post-dose ]
  • PK of Naproxen: Trough Plasma Concentrations [ Time Frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose ]
    Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.
Pharmacokinetic (PK) in terms of characteristics of VIMOVO (naproxen / esomeprazole). [ Time Frame: Month 1 and 3. ]
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 the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (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: naproxen/esomeprazole
  • Drug: VIMOVO 375/20
    375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
    Other Name: naproxen/esomeprazole
  • Drug: VIMOVO 500/20
    500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
    Other Name: naproxen/esomeprazole
Experimental: VIMOVO

Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.

The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.

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.
 
Completed
46
February 2015
February 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 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.
Sexes Eligible for Study: All
12 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01544114
D1120C00037
No
Not Provided
Not Provided
Horizon Pharma Ireland, Ltd., Dublin Ireland
Horizon Pharma Ireland, Ltd., Dublin Ireland
Not Provided
Study Director: Julie Ball, MS Horizon Pharma Ireland, Ltd., Dublin Ireland
Horizon Pharma Ireland, Ltd., Dublin Ireland
September 2017

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