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.
Juvenile Idiopathic Arthritis
Drug: 800 mg ibuprofen/26.6 mg famotidine
|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|
- 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.
- 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)
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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
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.
|Contact: Julie Ball, MSfirstname.lastname@example.org|
|Contact: Amy Grahn, MSemail@example.com|
|United States, California|
|University of California||Withdrawn|
|San Francisco, California, United States, 94143|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70118|
|Contact: Sarah Layburn 508-894-5377 firstname.lastname@example.org|
|Principal Investigator: Abraham Gedalia, MD|
|United States, Massachusetts|
|UMASS Memorial Children's Medical Center||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Ann Feloney, C-PNP 774-442-3874 email@example.com|
|Principal Investigator: Anthony Alario, MD|
|United States, Pennsylvania|
|Altoona Center for Clinical Research Altoona Arthritis||Recruiting|
|Duncansville, Pennsylvania, United States, 16635|
|Contact: Ashli Weyandt 814-693-0300 ext 154 firstname.lastname@example.org|
|Contact: Amber Woomer, LPN 814-693-0300 ext 156 email@example.com|
|Principal Investigator: Alan J Kivitz, MD|
|United States, Texas|
|Dell Children's Medical Center of Central Texas||Recruiting|
|Austin, Texas, United States, 78723|
|Contact: Jill Meredith, BSN 512-324-9999 ext 87152 jrMeredith@seton.org|
|Contact: Alisa Edwards, RN 512-324-9999 ext 87905 aaEdwards@seton.org|
|Principal Investigator: Ruy Carrasco, MD|
|Study Chair:||Daniel J Lovell, MD, MPH||Children's Hospital Medical Center, Cincinnati|