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

NCT01563185 | Completed Phase 4 Results

• 1 other identifier: HZ-CA-402
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA; ibuprofen; famotidine; pediatrics; for > 1 month

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)

  Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.

  Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)

Secondary Outcomes (10)

• Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores

  Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

• American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being

  Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

• American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index

  Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

• ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis

  Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

• American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration

  Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).

Study Arms (1)

DUEXIS

EXPERIMENTAL

800 mg ibuprofen/26.6 mg famotidine

Drug: 800 mg ibuprofen/26.6 mg famotidine

Interventions

800 mg ibuprofen/26.6 mg famotidine DRUG

Oral tablet taken three time per day

Also known as: DUEXIS

DUEXIS

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Patient is male or female, aged 10 years to 16 years, 11 months.
• 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.
• 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).
• 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.
• 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.
• Patient is able to swallow a DUEXIS tablet whole.
• 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.
• Female patients of childbearing potential and male patients must agree to use medically acceptable methods of contraception, including abstinence, throughout the entire study period.
• Patient is willing and able to comply with the prescribed treatment protocol and evaluations.

You may not qualify if:

• 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.
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
• JIA disease is severe as defined by either physician's or parent's global assessments \> 90 on a 100 point scale.
• 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.
• Active uveitis.
• Presence of any other rheumatic disease or major chronic infectious, inflammatory, immunologic disease (e.g., inflammatory bowel disease, hypogammaglobulinemia, or systemic lupus erythematosus, etc.).
• Presence at screening or history of any disease other than JIA that requires the use of chronic systemic corticosteroids.
• History of clinically significant drug or alcohol abuse.

Sponsors & Collaborators

• Amgen: lead
• Pediatric Rheumatology Collaborative Study Group: collaborator

Study Sites (5)

Children's Hospital

New Orleans, Louisiana, 70118, United States

Location

Floating Hospital for Children @ Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

UMASS Memorial Children's Medical Center

Worcester, Massachusetts, 01655, United States

Location

Altoona Center for Clinical Research Altoona Arthritis

Duncansville, Pennsylvania, 16635, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Julie Ball, Senior Director of Clinical Development & Operations
• Organization: Horizon Pharma

jball@horizonpharma.com

224-383-3059

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 26, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 16, 2024
• Results First Posted: December 23, 2015

Record last verified: 2024-11

Locations

US (5)