A pharmacodynamic and pharmacokinetic study to determine the clinical significance of drug interactions between azathioprine and sulfasalazine, Balsalazide or Pentasa in patients with inflammatory bowel disease.
The specific aims of the study are to estimate the proportion of clinically important leukopenia, defined as a total white blood cell (WBC) count <3,000 X 10 9/L, when SAS 4 g/day, Balsalazide 6.75 g/day, or Pentasa 4 g/day is combined with maintenance of remission treatment with a stable dose of 6MP or AZA in patients with one of the inflammatory bowel diseases (IBD), either ulcerative colitis (UC) or Crohn's disease. These estimates (and 95% CIs) will be computed at weeks 2, 4, 6, and 8 after adding SAS, Balsalazide, or Pentasa to AZA or 6MP therapy. The secondary aim is to estimate the change (and 95% CI) in total WBC count for each treatment group at weeks 2, 4, 6, and 8 after adding SAS, Balsalazide, or Pentasa to AZA or 6MP therapy.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000585-30
Application #
6415479
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
30
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
City
Rochester
State
MN
Country
United States
Zip Code
55905
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