The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if the combination of oral budesonide and rectal hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Budesonide; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Written, voluntary, informed consent given

• 18 years or older

• Speak and read English

• Extensive ulcerative colitis based upon endoscopy, histopathology, and clinical symptoms

• SCCAI Score > 3

• Presence of diarrhea (3 or more bowel movements per 24 hours) AND grossly visible blood in stool

Exclusion Criteria:

• Serum creatinine > 2.0 mg/dL

• Pregnant or breastfeeding

• Prior history of total or subtotal colectomy, or currently has an ostomy

• History or suspicion of Crohn's disease or Indeterminate colitis

• Diagnosis of any condition deemed by the investigator inhibiting completion of the trial

• Initiated therapy with or change in mesalamine dose within the last 4 weeks

• Change in azathioprine, 6-mercaptopurine, or cyclosporine within the last 8 weeks

• Currently taking or have used corticosteroids within the last 8 weeks

• Rectally administered mesalamine or steroids within the last 2 weeks

• Current or prior use of anti-TNF alpha agents within the last 8 weeks

• Experimental ulcerative colitis agents within the last 8 weeks

• Concomitant use of CYP3A4 activity inhibitor (e.g. ketoconazole, itraconazole, ritonavir, indinavir, erythromycin)

• Uncontrolled diabetes (HgA1c > 8.0) within 1 year

• Unstable Coronary artery disease/Class III/IV CHF

• Decompensated cirrhosis (e.g. encephalopathy, renal failure, ascites, GIB)

• Any known infection requiring antibiotics

• Active Clostridium difficile infection

• COPD requiring home oxygen

• HIV/AIDS with CD4 < 200 or AIDs-defining illnesses/infections