Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-01 @ 5:20 PM
Study NCT ID:
NCT00300118
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2006-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)
Sponsor:
Dr. Falk Pharma GmbH
Organization:
Study Overview
Official Title:
Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients
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 mesalazine or budesonide is more active in the treatment of active Crohn's disease.
Detailed Description:
Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.
So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.
So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2004-001213-34 | None | None | View |