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

NCT00805285 | Terminated Phase 2 Results DMC

• 1 other identifier: H-30365
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 if oral budesonide and rectal hydrocortisone has fewer and less severe side effects compared to standard steroids (prednisone).

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Disease; Ulcerative Colitis; Budesonide; Corticosteroids

Outcome Measures

Primary Outcomes (2)

• Simple Clinical Colitis Disease Activity (SCCAI)

  Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.

  0, 2, 4, 6, and 8 weeks

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  Scores range from 10-70 where higher scores indicated better quality of life.

  Week 0 and 8

Secondary Outcomes (3)

• ACTH Stimulation Test

  Week 16

• Adverse Events

  0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks

• C Reactive Protein

  Week 0 and 8

Study Arms (1)

Combination Oral Budesonide and Rectal Hydrocortisone

EXPERIMENTAL

See intervention

Drug: Combination Oral Budesonide and Rectal Hydrocortisone

Interventions

Combination Oral Budesonide and Rectal Hydrocortisone DRUG

Budesonide 9 mg PO (oral) daily and hydrocortisone 100 mL PR (enema) for an 8-week period. The doses of each drug to be used in the pilot study are standard doses used in clinical practice. After 8-weeks, the budesonide will be tapered in the following manner: 1) budesonide 6 mg PO daily and hydrocortisone 100 ml PR every other day (EOD) for 3 weeks then 2) budesonide 3 mg PO daily and hydrocortisone 100 ml PR 2 x per week for 3 weeks then 3) discontinue budesonide.

Also known as: Entocort

Combination Oral Budesonide and Rectal Hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written, voluntary, informed consent given
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated early by the University of Maryland HRPO secondary to limited recruitment of participants. This resulted in an inability to analyze the results.

Results Point of Contact

• Title: Raymond Cross, MD, MS
• Organization: University of Maryland, Baltimore

rcross@medicine.umaryland.edu

410-706-3387

Study Officials

• Raymond K Cross, MD, MS

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Leyla J Ghazi, MD

  University of Maryland, College Park

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: December 4, 2019
• Results First Posted: May 13, 2013

Record last verified: 2019-11

Locations

US (1)