Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092508
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2004-09-22
Brief Title:
CORE A Study of OPC-6535 With Asacol in Maintaining Ulcerative Colitis UC Remission
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
Phase 3 Multi-Center Randomized Double-Blind Parallel-Arm 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol in the Maintenance of Ulcerative Colitis Remission
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This dose comparison study taking place at over 200 sites worldwide will compare the dosing safety and efficacy of an investigational medicine OPC-6535 to the dosing safety and efficacy of Asacol in the maintenance of remission in subjects with ulcerative colitis
Detailed Description:
Objectives
This study will compare the safety and efficacy of 25 mg per day QD and 50 mg QD of OPC-6535 to 800 mg twice a day BID of Asacol in the maintenance of remission in subjects with ulcerative colitis
Subject Population
Subjects with ulcerative colitis currently in remission defined as rectal bleeding RB and flexible sigmoidoscopy FS scores of 0 on or off a stable dose of sulfasalazine or 5-ASA products for at least 6 weeks
Subjects must have had the diagnosis of ulcerative colitis established by prior colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the Screening Period
Subjects must have had treatment for a flare of ulcerative colitis with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period
Subjects may not have used corticosteroids topical agents corticosteroid or 5-ASA enemas suppositories foams azathioprine 6-mercaptopurine or methotrexate within 6 weeks of the Screening Period Upon entry sulfasalazine and 5-ASA containing products will be discontinued
Safety Vital signs ECGs laboratory studies including hematology clinical chemistry and urinalysis and adverse events
This study will compare the safety and efficacy of 25 mg per day QD and 50 mg QD of OPC-6535 to 800 mg twice a day BID of Asacol in the maintenance of remission in subjects with ulcerative colitis
Subject Population
Subjects with ulcerative colitis currently in remission defined as rectal bleeding RB and flexible sigmoidoscopy FS scores of 0 on or off a stable dose of sulfasalazine or 5-ASA products for at least 6 weeks
Subjects must have had the diagnosis of ulcerative colitis established by prior colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the Screening Period
Subjects must have had treatment for a flare of ulcerative colitis with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period
Subjects may not have used corticosteroids topical agents corticosteroid or 5-ASA enemas suppositories foams azathioprine 6-mercaptopurine or methotrexate within 6 weeks of the Screening Period Upon entry sulfasalazine and 5-ASA containing products will be discontinued
Safety Vital signs ECGs laboratory studies including hematology clinical chemistry and urinalysis and adverse events
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