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

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ClinicalTrials.gov Identifier: NCT00805285
Recruitment Status : Terminated (Study terminated due to insufficient enrollment)
First Posted : December 9, 2008
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
University of Maryland, Baltimore ( University of Maryland, College Park )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammatory Bowel Disease
Ulcerative Colitis
Intervention Drug: Combination Oral Budesonide and Rectal Hydrocortisone
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Lack of Efficacy             1
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description Intervention Arm
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
The only enrolled patient was withdrawn secondary to disease worsening.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
45  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Simple Clinical Colitis Disease Activity (SCCAI)
Hide Description Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.
Time Frame 0, 2, 4, 6, and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description:
Intervention Arm
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Hide Description Scores range from 10-70 where higher scores indicated better quality of life.
Time Frame Week 0 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description:
Intervention Arm
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title ACTH Stimulation Test
Hide Description An increase in cortisol after stimulation by ACTH is normal. Blood cortisol after ACTH stimulation should be greater than 18 - 20 mcg/dL, depending on the dose of cosyntropin used.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description:
Intervention Arm
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame 0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description:
Intervention Arm
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Adverse events
2
5.Secondary Outcome
Title C Reactive Protein
Hide Description Higher values indicated increased disease activity
Time Frame Week 0 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description:
Intervention Arm
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Oral Budesonide and Rectal Hydrocortisone
Hide Arm/Group Description Intervention Arm
All-Cause Mortality
Combination Oral Budesonide and Rectal Hydrocortisone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Oral Budesonide and Rectal Hydrocortisone
Affected / at Risk (%)
Total   1/1 (100.00%) 
Gastrointestinal disorders   
Worsening of ulcerative colitis  1/1 (100.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Oral Budesonide and Rectal Hydrocortisone
Affected / at Risk (%)
Total   1/1 (100.00%) 
Vascular disorders   
Portal vein and superior mesenteric vein thrombosis [1]  1/1 (100.00%) 
[1]
The only enrolled patient was found to have a portal and superior mesenteric vein thrombosis. This was thought to be related to the underlying ulcerative colitis and not related to the intervention.
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Raymond Cross, MD, MS
Organization: University of Maryland, Baltimore
Phone: 410-706-3387
EMail: rcross@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: University of Maryland, Baltimore ( University of Maryland, College Park )
ClinicalTrials.gov Identifier: NCT00805285     History of Changes
Other Study ID Numbers: H-30365
First Submitted: December 8, 2008
First Posted: December 9, 2008
Results First Submitted: January 24, 2013
Results First Posted: May 13, 2013
Last Update Posted: May 13, 2013