EDWARDS FC, TRUELOVE SC THE COURSE AND PROGNOSIS OF ULCERATIVE COLITIS. III. COMPLICATIONS. Gut. 1964 Feb;5:1-22.
Kaplan HP, Portnoy B, Binder HJ, Amatruda T, Spiro H A controlled evaluation of intravenous adrenocorticotropic hormone and hydrocortisone in the treatment of acute colitis. Gastroenterology. 1975 Jul;69(1):91-5.
Mager DE, Lin SX, Blum RA, Lates CD, Jusko WJ Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics. J Clin Pharmacol. 2003 Nov;43(11):1216-27.
Meyers S, Lerer PK, Feuer EJ, Johnson JW, Janowitz HD Predicting the outcome of corticoid therapy for acute ulcerative colitis. Results of a prospective, randomized, double-blind clinical trial. J Clin Gastroenterol. 1987 Feb;9(1):50-4.
Sood A, Midha V, Sood N, Awasthi G A prospective, open-label trial assessing dexamethasone pulse therapy in moderate to severe ulcerative colitis. J Clin Gastroenterol. 2002 Oct;35(4):328-31.
Stein RB, Hanauer SB Medical therapy for inflammatory bowel disease. Gastroenterol Clin North Am. 1999 Jun;28(2):297-321. Review.
Truelove SC, Jewell DP Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet. 1974 Jun 1;1(7866):1067-70.
Truelove SC The management of ulcerative colitis. Br J Clin Pract. 1974 Jan;28(1):5-10.
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
