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Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

NCT01033305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2012-04-19

No results posted yet for this study

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.

Conditions

  • Mild to Moderate Ulcerative Colitis

Interventions

DRUG

CyCol™

Orally, once per day for 4 weeks

DRUG

Placebo

Orally, once per day for 4 weeks

Sponsors & Collaborators

  • Sigmoid Pharma

    lead INDUSTRY

Principal Investigators

  • Diarmuid O'Donoghue, Prof · St Vincent's University Hospital

  • Stuart Bloom, M.D. · University College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033305 on ClinicalTrials.gov