Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450086
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2007-03-20
Brief Title:
Budesonide Capsules vs Mesalazine Granules vs Placebo in Collagenous Colitis
Sponsor:
Dr Falk Pharma GmbH
Organization:
Dr Falk Pharma GmbH
Study Overview
Official Title:
Double-blind Double-dummy Randomised Placebo-controlled Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs Mesalazine Granules vs Placebo for Patients With Collagenous Colitis
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis
Detailed Description:
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis which is chronic or recurrent non-bloody watery diarrhea
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 |
|---|---|---|---|
| 2006-004159-39 | None | None | None |