Trial Outcomes & Findings for The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis (NCT NCT00805285)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

0, 2, 4, 6, and 8 weeks

Results posted on

2019-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Oral Budesonide and Rectal Hydrocortisone Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Oral Budesonide and Rectal Hydrocortisone Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
Overall Study Lack of Efficacy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Oral Budesonide and Rectal Hydrocortisone n=1 Participants Intervention Arm
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	45 years STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 0, 2, 4, 6, and 8 weeks

Population: The only patient enrolled withdrew; there was no data to analyze.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 0 and 8

Population: The only patient enrolled withdrew; there was no data to analyze.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

Population: The only patient enrolled withdrew; there was no data to analyze.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Combination Oral Budesonide and Rectal Hydrocortisone n=1 Participants Intervention Arm
Adverse Events	2 Adverse events

SECONDARY outcome

Timeframe: Week 0 and 8

Population: The only patient enrolled withdrew; there was no data to analyze.

Higher values indicated increased disease activity

Outcome measures

Outcome data not reported

Adverse Events

Combination Oral Budesonide and Rectal Hydrocortisone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Oral Budesonide and Rectal Hydrocortisone n=1 participants at risk Intervention Arm
Gastrointestinal disorders Worsening of ulcerative colitis	100.0% 1/1

Other adverse events

Other adverse events
Measure	Combination Oral Budesonide and Rectal Hydrocortisone n=1 participants at risk Intervention Arm
Vascular disorders Portal vein and superior mesenteric vein thrombosis	100.0% 1/1

Additional Information

Raymond Cross, MD, MS

University of Maryland, Baltimore

Phone: 410-706-3387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place