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Juvenile Idiopathic ArthritisPhase 4NCT01563185

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

A Phase 4 study testing 800 mg ibuprofen/26.6 mg famotidine in people with Juvenile Idiopathic Arthritis, run by Amgen at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 16 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
800 mg ibuprofen/26.6 mg famotidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
5 sitesUnited States
Study dates
Apr 2012to Mar 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Presence at screening of any of the following laboratory values:
  • Hemoglobin < 9.0 g/dL
  • White blood cells < 2000/mm^3 (2 x 109/L)
  • Platelets < 150,000/mm^3 (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.
  • Methotrexate > 20 mg/M^2/week or > 40 mg/week.
  • 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.
  • Females who are pregnant or breast feeding.
  • Female patient has a positive serum pregnancy test at Screening and/or a positive urine pregnancy test at Study Day 0.
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Floating Hospital for Children @ Tufts Medical Center

    Boston, Massachusetts, 02111

  • Altoona Center for Clinical Research Altoona Arthritis

    Duncansville, Pennsylvania, 16635

  • Children's Hospital

    New Orleans, Louisiana, 70118

  • UMASS Memorial Children's Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Multicenter, Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis

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.

Read the 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.

Study with completed results acquired from Horizon in 2024

Being tested
800 mg ibuprofen/26.6 mg famotidine
Keywords
JIA, ibuprofen, famotidine, pediatrics, for > 1 month
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 800 mg ibuprofen/26.6 mg famotidineDrug

    Also called DUEXIS

    Oral tablet taken three time per day

Study groups in NCT01563185
Study groupRoleWhat they receive
DUEXISExperimental800 mg ibuprofen/26.6 mg famotidine
Receives: Drug: 800 mg ibuprofen/26.6 mg famotidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

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

    To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:

    Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health.

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

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

    The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).

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

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

    The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).

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

  4. 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

    The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.

    The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5.

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

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

    The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.

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

  6. Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax)

    Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

    Measured: Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose

  7. Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax)

    Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

    Measured: Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose

  8. Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t))

    AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.

    Measured: Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose

  9. Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F)

    CL/F was estimated in ibuprofen and famotidine.

    Measured: Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group

  10. Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F)

    V/F were estimated in ibuprofen and famotidine.

    Measured: Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563185
Sponsor's protocol ID
HZ-CA-402
Status last verified
Nov 2024
First submitted
20 Mar 2012
Last updated
16 Dec 2024
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 800 mg ibuprofen/26.6 mg famotidine in people with Juvenile Idiopathic Arthritis, run by Amgen at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) (time frame: Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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