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

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 July 23, 2014