Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

This study has been completed.
Pediatric Rheumatology Collaborative Study Group
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland Identifier:
First received: March 20, 2012
Last updated: April 16, 2015
Last verified: April 2015

The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks.

The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.

Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: 800 mg ibuprofen/26.6 mg famotidine
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 Multicenter, Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

Resource links provided by NLM:

Further study details as provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:

Primary Outcome Measures:
  • Safety of chronic treatment with DUEXIS in patients with JIA. [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Adverse events (AEs), physical examinations (including vital signs and weight), and clinical laboratory assessments. Endoscopic examinations will be performed only if clinically indicated, based on the judgment of the Investigator.

Secondary Outcome Measures:
  • Single dose PK study in a subset of patients with multiple dose PK sampling from all enrolled patients. [ Time Frame: Single dose Day 0 and Week 4; Multidose up to 24 weeks ] [ Designated as safety issue: No ]
    PK analysis of famotidine and ibuprofen single dose plasma concentration data using standard non-compartmental methods. Maximum concentration (Cmax), time to Cmax (Tmax), Area Under the Curve (AUC) time frame: pre-dose, 0.5, 1, 2, 4 and 8 - 10 hours post dose, and AUC(0-inf) will be determined. A population PK analysis of ibuprofen and famotidine will also be performed using nonlinear mixed effect modeling.

  • Efficacy using American College of Rheumatology (ACR) Pediatric core set measures of JIA activity will be assessed at each study visit. [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    ACR core set evaluations for pediatrics will be used to measure change from baseline to each visit.

  • Quality of Life (QOL) [ Time Frame: Day 0 and last visit up to 24 weeks ] [ Designated as safety issue: No ]
    Child Health Questionnaire (CHQ)

Enrollment: 12
Study Start Date: April 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DUEXIS
800 mg ibuprofen/26.6 mg famotidine
Drug: 800 mg ibuprofen/26.6 mg famotidine
Oral tablet taken three time per day
Other Name: DUEXIS

Detailed Description:
Approximately 30 JIA patients who meet all eligibility criteria and who are expected to require daily administration of an NSAID for up to 24 weeks will be enrolled. A subset of approximately 6 patients will participate in a single dose PK study at Day 0 with an abbreviated PK profile performed at Week 4 if possible. Multiple dose PK sampling will occur in all enrolled patients.

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient and guardian are willing to consent to undergo up to 24 weeks of treatment with DUEXIS (ibuprofen 800 mg/famotidine 26.6 mg) oral tablet three times daily.
  2. Patient is male or female, aged 10 years to 16 years, 11 months.
  3. Patient is diagnosed with JIA for > 1 month including oligoarthritis, polyarthritis rheumatoid factor (RF) +, polyarthritis RF-, psoriatic arthritis, enthesitis-related arthritis, or undifferentiated and systemic arthritis without systemic features in the past 6 months.
  4. Patient must have currently active articular disease as defined by > 1 active joint (i.e., presence of swelling, or if no swelling is present, limitation of motion [LOM] accompanied by pain, tenderness, or both).
  5. Based upon investigator judgment, given current treatment patient is receiving and level of disease activity, it is determined appropriate for the patient to undergo up to 24 weeks of treatment with DUEXIS (ibuprofen 800 mg/famotidine 26.6 mg) oral tablet three times daily. The investigator will use his/her clinical judgment in determining the duration of treatment for the patient based on the standard of care up to 24 weeks of treatment.
  6. Weight > 48 kg and body mass index (BMI) > 5th percentile using the Centers for Disease Control (CDC) BMI percentile calculator for child and teen at the screening visit.
  7. Patient is able to swallow a DUEXIS tablet whole.
  8. For the single dose pharmacokinetic (PK) subset, patients and guardians must be willing to participate in the serial blood sample collections at Day 0 and Week 4.
  9. Female patients of childbearing potential and male patients must agree to use medically acceptable methods of contraception, including abstinence, throughout the entire study period.
  10. Patient is willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

  1. Patient has a history of or experienced any of the following:

    • NSAID-associated and/or primary peptic ulcer disease-associated serious gastrointestinal complications such as perforation of ulcers, gastric outlet obstruction due to ulcers, and/or acute gastrointestinal bleeding
    • NSAID-induced asthma exacerbation, acute renal failure, interstitial nephritis, and/or hepatitis
    • Malignant disease of the gastrointestinal tract
    • Erosive esophagitis
    • Coronary artery bypass graft (CABG) surgery within the 14 days prior to study Day 0
    • Uncontrolled diabetes mellitus as evidenced by Hemoglobin A1c > 7%
    • Known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C.
  2. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
  3. JIA disease is severe as defined by either physician's or parent's global assessments > 90 on a 100 point scale.
  4. Systemic JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.
  5. Active uveitis.
  6. Presence of any other rheumatic disease or major chronic infectious, inflammatory, immunologic disease (e.g., inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus, etc.).
  7. Presence at screening or history of any disease other than JIA that requires the use of chronic systemic corticosteroids.
  8. History of clinically significant drug or alcohol abuse.
  9. Presence at screening of any of the following laboratory values:

    • Hemoglobin < 9.0 g/dL
    • White blood cells < 2000/mm3 (2 x 109/L)
    • Platelets < 150,000/mm3 (150 x 109/L)
    • Serum creatinine > 1.5 times upper limit of normal
    • Serum ALT or AST > 2.0 times upper limit of normal
    • H. pylori positive
    • Any other lab value that in the opinion of the investigator might place the patient at unacceptable risk for participation in this study.
  10. Methotrexate > 20 mg/M2/week or > 40 mg/week.
  11. Patient currently is participating in an investigational drug study, or patient participated in an investigational drug study within the 30 days (or < 5 terminal half-lives of elimination) prior to study entry.
  12. Females who are pregnant or breast feeding.
  13. Female patient has a positive serum pregnancy test at Screening and/or a positive urine pregnancy test at Study Day 0.
  14. Patient has a concomitant disease or condition that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk
  Contacts and Locations
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Please refer to this study by its identifier: NCT01563185

United States, Louisiana
Children's Hospital
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
Floating Hospital for Children @ Tufts Medical Center
Boston, Massachusetts, United States, 02111
UMASS Memorial Children's Medical Center
Worcester, Massachusetts, United States, 01655
United States, Pennsylvania
Altoona Center for Clinical Research Altoona Arthritis
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Sponsors and Collaborators
Horizon Pharma Ireland, Ltd., Dublin Ireland
Pediatric Rheumatology Collaborative Study Group
Study Chair: Daniel J Lovell, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland Identifier: NCT01563185     History of Changes
Other Study ID Numbers: HZ-CA-402
Study First Received: March 20, 2012
Last Updated: April 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:
for > 1 month

Additional relevant MeSH terms:
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 27, 2015