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

This study is currently recruiting participants.
Verified April 2014 by Horizon Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01544114
First received: February 21, 2012
Last updated: April 2, 2014
Last verified: April 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 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: 45
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544114

Contacts
Contact: Mark Hendricks 619-684-1381 Mark.Hendricks@quintiles.com
Contact: Julie Ball 224-383-3059 jball@horizonpharma.com

Locations
United States, Arkansas
Research Site Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Kathy Thessing    501-364-2715    thessingkathy@uams.edu   
Principal Investigator: Jason Dare, MD         
United States, California
Research Site Recruiting
San Francisco, California, United States, 94143
Contact: Mignon Hills    415-509-2897    hillsm@peds.ucsf.edu   
Principal Investigator: Emily von Scheven, MD         
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States, 80045
Contact: Nanastasia Welnik    720-777-8608    Nanastasia.Welnick@childrenscolorado.org   
Principal Investigator: J. Roger Hollister, MD         
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20010
Contact: Nicole Battle    202-476-4979    NBattle@childrensnational.org   
Principal Investigator: Lawrence K Jung, MD         
United States, Florida
Research Site Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Janette Groth    561-238-3034    jgroth@januspsychresearch.com   
Principal Investigator: Michael Belcon, MD         
United States, Georgia
Research Site Recruiting
Augusta, Georgia, United States, 30912
Contact: Heidi Stapp    706-721-7699    HSTAPP@gru.edu   
Principal Investigator: Rita S Jerath, MBChB         
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637
Contact: Rebecca Puplava    773-702-2879    rpuplava@peds.bsd.uchicago.edu   
Principal Investigator: Karen B Onel, MD         
United States, Nebraska
Research Site Recruiting
Omaha, Nebraska, United States, 68114
Contact: Kym Abraham    402-559-2977    kabraham@unmc.edu   
Principal Investigator: Adam Reinhardt, MD         
United States, New Jersey
Research Site Withdrawn
Livingston, New Jersey, United States, 07039
United States, New York
Research Site Recruiting
Brooklyn, New York, United States, 11203
Contact: Catherine Calacanis    718-270-4715    catherine.calacanis@downstate.edu   
Principal Investigator: Hamid Moallem, MD         
Research Site Recruiting
New Hyde Park, New York, United States, 11040
Contact: Marilyn Orlando    516-472-3709    morlando@nshs.edu   
Principal Investigator: Beth S Gottlieb, MD         
Research Site Recruiting
New York, New York, United States, 10021
Contact: Katia Sherman    212-606-1150    shermany@hss.edu   
Principal Investigator: Thomas J Lehman, MD         
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Tina Sherrard    513-636-1445    Tina.Sherrard@cchmc.org   
Principal Investigator: Daniel J Lovell, MD, MPH         
Research Site Recruiting
Cleveland, Ohio, United States, 44195
Contact: Debra Latham    216-445-4944    lathamd2@ccf.org   
Principal Investigator: Andrew S Zeft, MD         
Sub-Investigator: Steven J Spalding, MD         
Research Site Active, not recruiting
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Marsha Simmons    215-427-5360    marsha.simmons@drexelmed.edu   
Principal Investigator: Donald Goldsmith, MD         
United States, Tennessee
Research Site Recruiting
Memphis, Tennessee, United States, 38119
Contact: Manju Gupta    901-681-9670    smartmanju@hotmail.com   
Principal Investigator: Ramesh C Gupta, MD         
United States, Virginia
Research Site Recruiting
Fairfax, Virginia, United States, 22030
Contact: Chidima M Ioanou    571-308-1905    cmartin@oandoalpan.com   
Principal Investigator: Oral Alpan, MD         
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: April 2, 2014
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
Naproxen
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014