Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209300
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily
Status:
COMPLETED
Status Verified Date:
2011-05
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:
This is a multi-centre randomised controlled investigator blinded study The randomisation will be done centrally The patients will be treated for 1 year with clinical and laboratory assessments at 0 4 8 and 12 months
Endoscopic examination is at enrollment and on completion of the study at relapse or after 12 months
Number of Subjects Planned and Analysed
360 patients for demonstration of non-inferiority between once daily and twice daily
326 to be analysed in per-protocol PP analyses and
360 in intention-to-treat ITT analyses
Endoscopic examination is at enrollment and on completion of the study at relapse or after 12 months
Number of Subjects Planned and Analysed
360 patients for demonstration of non-inferiority between once daily and twice daily
326 to be analysed in per-protocol PP analyses and
360 in intention-to-treat ITT analyses
Detailed Description:
None
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 |
|---|---|---|---|
| 2004-004565-15 | None | None | None |