Trial Outcomes & Findings for Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis (NCT NCT00217022)

Results Overview

Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Three out of last four weeks that the subject was on the study

Results posted on

2021-11-02

Participant Flow

Participants were recruited from Mayo Clinic, Rochester, Minnesota from June 2003 - February 2008.

Participant milestones

Participant milestones
Measure	Budesonide 9 mg daily	Placebo three tablets daily
Overall Study STARTED	12	4
Overall Study COMPLETED	11	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Budesonide 9 mg daily	Placebo three tablets daily
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Budesonide n=12 Participants 9 mg daily	Placebo n=4 Participants three tablets daily	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 19 • n=5 Participants	59 years STANDARD_DEVIATION 12 • n=7 Participants	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	4 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Three out of last four weeks that the subject was on the study

Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.

Outcome measures

Outcome measures
Measure	Budesonide n=11 Participants 9 mg daily	Placebo n=4 Participants three tablets daily
Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks	11 participants	4 participants

SECONDARY outcome

Timeframe: Baseline (day 1 of study) and at eight weeks (approximately)

Population: Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.

The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale ("normal" (0), "mildly increased" (1), "moderately increased" (2), "severely increased" (3)).

Outcome measures

Outcome measures
Measure	Budesonide n=8 Participants 9 mg daily	Placebo n=3 Participants three tablets daily
Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies	7 participants	1 participants

Adverse Events

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Darrell Pardi

Mayo Clinic, Rochester MN

Phone: 507-538-1231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place