Abstract

The aim of this study is to assess the efficacy and safety of budesonide compared to placebo in patients with active Crohn's disease affecting the ileum and/or the ascending colon. Approximately 200 patients nationwide will be randomized to 4.5 or 9 mg controlled ileal release capsules once or twice a day, or placebo. Budesonide is a glucocortisosteroid with high topical antiinflammatory activity and significant first-pass metablism. The primary efficacy variable will be the Crohn's Disease Activity Index remission rate.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR002558-13
Application #
6281698
Study Section
Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
13
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

Name
University of Texas Health Science Center Houston
Department
Type
DUNS #
City
Houston
State
TX
Country
United States
Zip Code
77225

  Publications

Chappell, Cynthia L; Darkoh, Charles; Shimmin, Lawrence et al. (2016) Fecal Indole as a Biomarker of Susceptibility to Cryptosporidium Infection. Infect Immun 84:2299-306
Liao, George P; Harting, Matthew T; Hetz, Robert A et al. (2015) Autologous bone marrow mononuclear cells reduce therapeutic intensity for severe traumatic brain injury in children. Pediatr Crit Care Med 16:245-55
Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23
Chappell, Cynthia L; Okhuysen, Pablo C; Langer-Curry, Rebecca C et al. (2015) Cryptosporidium muris: infectivity and illness in healthy adult volunteers. Am J Trop Med Hyg 92:50-5
Reveille, John D (2014) An update on the contribution of the MHC to AS susceptibility. Clin Rheumatol 33:749-57
Bethi, Siddharth; Dasgupta, Abhijit; Weisman, Michael H et al. (2013) Functional limitations due to axial and peripheral joint impairments in patients with ankylosing spondylitis: are focused measures more informative? Arthritis Care Res (Hoboken) 65:607-14
Ward, Michael M; Learch, Thomas J; Gensler, Lianne S et al. (2013) Regional radiographic damage and functional limitations in patients with ankylosing spondylitis: differences in early and late disease. Arthritis Care Res (Hoboken) 65:257-65
Benjamin-Garner, Ruby; Stotts, Angela (2013) Impact of smoking exposure change on infant birth weight among a cohort of women in a prenatal smoking cessation study. Nicotine Tob Res 15:685-92
Ornstein, Tisha J; Max, Jeffrey E; Schachar, Russell et al. (2013) Response inhibition in children with and without ADHD after traumatic brain injury. J Neuropsychol 7:1-11
Murthy, Vijaya; Willis, Rohan; Romay-Penabad, Zurina et al. (2013) Value of isolated IgA anti-?2 -glycoprotein I positivity in the diagnosis of the antiphospholipid syndrome. Arthritis Rheum 65:3186-93

Showing the most recent 10 out of 396 publications