Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350415
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2006-07-06
Brief Title:
A Double Blind Study for the Treatment of Acute Ulcerative Colitis
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
A Double-blind Randomized 6-week Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 48 gDay Versus Asacol 24 gDay for the Treatment of Moderately Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2013-04
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:
A Double-blind Randomized 6-week Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 48 gday 800 mg mesalamine tablet versus Asacol 24 gday 400 mg mesalamine tablet for the Treatment of Moderately Active Ulcerative Colitis ASCEND III
Detailed Description:
This is a double-blind randomized multi-center multi-national active-control study in patients who are experiencing a moderately active flare of UC Patients will be randomly assigned to receive either Asacol 24 gday 400 mg tablet or Asacol 48 gday 800 mg tablet for 6 weeks Patients will be randomized to one of the 2 treatment groups in a 11 ratio The objective of the study is to evaluate the safety and efficacy of Asacol 48 gday 800 mg tablet compared to Asacol 24 gday 400 mg tablet in this patient population Following successful screening patients will be randomized to one of the two treatment arms Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks
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