Abstract

The hypothesis of this Phase III clinical trial is that treatment for 24 weeks with a daily dosage of 450 IU of human interferon alpha is safe and will significantly increase stimulated saliva production compared to placebo in subjects with primary Sjogren's syndrome. The primary objective will be measured by changes in stimulated whole saliva production. Secondary objectives will be measured by 100mm visual analog scales and other patient questionnaires. Change from baseline will be calculated for all secondary objective variable. The other objective is safety. This will be met by comparing adverse event reports and changes in laboratory variables.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000400-32
Application #
6409103
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
32
Fiscal Year
2000
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
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
Ostrem, Joseph D; Evanoff, Nicholas G; Ryder, Justin R et al. (2017) High-flow-mediated constriction in adults is not influenced by biomarkers of cardiovascular and metabolic risk. J Clin Ultrasound 45:35-42
Nelson, Brent G; Bassett, Danielle S; Camchong, Jazmin et al. (2017) Comparison of large-scale human brain functional and anatomical networks in schizophrenia. Neuroimage Clin 15:439-448
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

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