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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
  Purpose
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with 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: Intervention Model: Single Group Assignment
Masking: None (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 Ireland, Ltd., Dublin Ireland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: April 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, D.C., 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 Ireland, Ltd., Dublin Ireland
Investigators
Study Director: Julie Ball, MS Horizon Pharma Ireland, Ltd., Dublin Ireland
  More Information

Additional Information:
Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT01544114     History of Changes
Other Study ID Numbers: D1120C00037
First Submitted: February 21, 2012
First Posted: March 5, 2012
Results First Submitted: August 4, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017

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