Status:
TERMINATED
The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Inflammatory Bowel Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Ulcerative colitis (UC) is a common chronic inflammatory condition of the intestines that results in bloody diarrhea, abdominal pain, and extraintestinal manifestations of disease. The disease course ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00805285
Start Date
October 1 2008
End Date
March 1 2010
Last Update
December 4 2019
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201