Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01033305
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2009-12-15
Brief Title:
Oral Ciclosporin for Colonic Release in Ulcerative Colitis CyCol
Sponsor:
Sigmoid Pharma
Organization:
Sigmoid Pharma
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin CyCol in the Treatment of Mild to Moderate Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2012-04
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:
This is a multi-center study in Ireland and United Kingdom to determine the effects safety and tolerability of a drug called CyCol in improving mild to moderate ulcerative colitis UC
Informed consent will be obtained and following confirmation of eligibility and disease assessment study participants will be randomised allocated by chance to take either CyCol or placebo orally once every day for four weeks Study visit assessments will include blood and stool tests physical examinations and flexible sigmoidoscopies inspection of the bowel wall using a flexible camera
Half the participants will receive CyCol and half will receive placebo At the end of treatment 4 weeks study participants will be reassessed again and the findings in those who received CyCol will be compared with those who received placebo Any side effects experienced during the study and the safety of treatment with CyCol will also be evaluated
Informed consent will be obtained and following confirmation of eligibility and disease assessment study participants will be randomised allocated by chance to take either CyCol or placebo orally once every day for four weeks Study visit assessments will include blood and stool tests physical examinations and flexible sigmoidoscopies inspection of the bowel wall using a flexible camera
Half the participants will receive CyCol and half will receive placebo At the end of treatment 4 weeks study participants will be reassessed again and the findings in those who received CyCol will be compared with those who received placebo Any side effects experienced during the study and the safety of treatment with CyCol will also be evaluated
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