Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300118
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2006-03-07
Brief Title:
Oral Budesonide vs Oral Mesalazine in Active Crohns Disease CD
Sponsor:
Dr Falk Pharma GmbH
Organization:
Dr Falk Pharma GmbH
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 45 g in Moderately Active Crohns 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 Crohns disease
Detailed Description:
Crohns disease is often treated with glucocorticoids or mesalazine Both drugs are indicated for active Crohns disease Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohns disease Budesonide 9 mgday or mesalazine 45 gday 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 ie Budenofalk capsules 9 mgday and Salofalk tablets Eudragit-L-coated oral mesalazine 45 gday in moderately active Crohns 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 ie Budenofalk capsules 9 mgday and Salofalk tablets Eudragit-L-coated oral mesalazine 45 gday in moderately active Crohns disease Mesalazine is used in this trial as a comparator
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 |
|---|---|---|---|
| 2004-001213-34 | None | None | None |