Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01033305
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2009-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)
Sponsor:
Sigmoid Pharma
Organization:
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:
True
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?: