Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217022
Status:
TERMINATED
Last Update Posted:
2021-11-02
First Post:
2005-09-14
Brief Title:
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Trial of Budesonide for the Treatment of Active Lymphocytic Colitis
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed early because of low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis This study includes stool collections blood draws weekly questionnaires and a sigmoidoscopy The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis
Detailed Description:
Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea with two main subtypes collagenous and lymphocytic colitis Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis but few treatments have been evaluated in randomized controlled trials Thus treatment is guided mostly by anecdotal reports case series and physicians experience In our uncontrolled experience corticosteroids are one of the most effective therapies for microscopic colitis but are not typically used as a first line therapy because of toxicity Budesonide has been reported to be of clinical benefit in small uncontrolled series of patients with microscopic colitis and recent controlled trials showed that it is superior to placebo in collagenous colitis We propose a study of budesonide in patients with the lymphocytic type of microscopic colitis
Patients will have stool specimen and blood drawn at the start of the study Patient will take either Budesonide or placebo for 8 weeks At the end of treatment patient will have stool collection and sigmoidoscopy
Patients will have stool specimen and blood drawn at the start of the study Patient will take either Budesonide or placebo for 8 weeks At the end of treatment patient will have stool collection and sigmoidoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUSBUEN0002 | OTHER | None | None |
| UL1RR024150 | NIH | AstraZeneca | httpsreporternihgovquickSearchUL1RR024150 |