Abstract

MK-0966 is a specific inhibitor of cyclooxygenase-2. It has recently been approved for use in adults. The pharmacokinetic (PK) profile of MK-0966 has not been assessed in children. The primary objectives of this study are to evaluate the steady state PK profile of MK-0966 in adolescent JRA children (12-17) compared to historical data from adults, to evaluate the safety and tolerability of MK-0966 in adolescents with JRA, and to gain experience in designing future studies with clinical measurements for assessing JRA. The hypotheses are that the PK profile of MK-0966 in adolescents with JRA will be similar to that observed with adult historical controls, when dose is adjusted for weight; and that administration of MK-0966 will be sufficiently safe and well tolerated by adolescents to proceed with further studies. This is a two-part protocol. Part I is a 14-day, open, oral dose, single-period study to evaluate the stead-state plasma-concentration profile of MK-0966 in JRA subjects aged 12-17. In Part II, subjects who successfully complete Part I will be eligible for randomization in a double-blind fashion to receive either MK-0966 at one of two dose levels or naproxen at one of two different dose levels for 12 weeks. We are applying to use the GCRC for some of the outpatient visits.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000400-33
Application #
6440684
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
33
Fiscal Year
2001
Total Cost
Indirect Cost

  Institution

Name
University of Minnesota Twin Cities
Department
Type
DUNS #
168559177
City
Minneapolis
State
MN
Country
United States
Zip Code
55455

  Publications

Harbin, Michelle M; Zavala, Hanan; Ryder, Justin R et al. (2018) Associations of sex, age and adiposity in endothelium-independent dilation in children. Physiol Meas 39:045002
Arikawa, Andrea Y; Kaufman, Beth C; Raatz, Susan K et al. (2018) Effects of a parallel-arm randomized controlled weight loss pilot study on biological and psychosocial parameters of overweight and obese breast cancer survivors. Pilot Feasibility Stud 4:17
Foster, Eric D; Bridges, Nancy D; Feurer, Irene D et al. (2018) Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 41:1001-1008
Ketterl, Tyler G; Chow, Eric J; Leisenring, Wendy M et al. (2018) Adipokines, Inflammation, and Adiposity in Hematopoietic Cell Transplantation Survivors. Biol Blood Marrow Transplant 24:622-626
Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group; Krischer, Jeffrey P; Schatz, Desmond A et al. (2017) Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 318:1891-1902
Kotlyar, Michael; Thuras, Paul; Hatsukami, Dorothy K et al. (2017) Sex differences in physiological response to the combination of stress and smoking. Int J Psychophysiol 118:27-31
Cole, Abigail J; Kuchnia, Adam J; Beckman, Lauren M et al. (2017) Long-Term Body Composition Changes in Women Following Roux-en-Y Gastric Bypass Surgery. JPEN J Parenter Enteral Nutr 41:583-591
Di Bisceglie, A M; Lombardero, M; Teckman, J et al. (2017) Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat 24:320-329
Beckman, Lauren M; Boullata, Joseph I; Fisher, Paige L et al. (2017) Evaluation of Lean Body Weight Equation by Dual-Energy X-Ray Absorptiometry Measures. JPEN J Parenter Enteral Nutr 41:392-397
Marwaha, A K; Panagiotopoulos, C; Biggs, C M et al. (2017) Pre-diagnostic genotyping identifies T1D subjects with impaired Treg IL-2 signaling and an elevated proportion of FOXP3+IL-17+ cells. Genes Immun 18:15-21

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