Condition category
Digestive System
Date applied
26/05/2005
Date assigned
20/07/2005
Last edited
30/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher J Hawkey

ORCID ID

Contact details

Wolfson Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 9709353
cj.hawkey@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

UC CAT

Study hypothesis

Does use of oral microemulsion ciclosporin, followed by azathioprine, in patients admitted to hospital with acute severe ulcerative colitis reduce the need for colectomy in the short term (at six months), and long term (two years)?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Severe ulcerative colitis

Intervention

Oral microemulsion of ciclosporin (5.5 to 6.5 mg/kg/day twice a day [bd]) or matched placebo.
All patients continue to receive intravenous hydrocortisone and other standard medical therapy. At discharge, patients will start treatment with azathioprine (50 mg daily, increasing to 2 mg/kg after two weeks) and a tapering dose of prednisolone.

Updated 30/07/2014: the trial was stopped due to poor recruitment.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ciclosporin, azathioprine, hydrocortisone, prednisolone

Primary outcome measures

All Patients Treated disease status at six months, defined as:
Treatment success = no colectomy and remission off steroid therapy
Partial treatment success = symptoms of active disease, or treatment with steroids (oral or enema)
Treatment failure = colectomy

Secondary outcome measures

1. Treatment outcome at two years (All Patients Treated disease status as defined for primary end-point above)
2. Treatment outcome at three months (All Patients Treated disease status as defined for primary outcome above)
3. Treatment response at 7 days (three or fewer non-bloody stools)
4. Time to remission and time to subsequent relapse measured by life table analysis
5. Quality of life at 6 months assessed using the McMaster inflammatory bowel disease questionnaire and EQ-5D scores
6. Overall incidence of adverse events
7. Employment status and amount of sick leave during follow-up
8. Patients valuation of outcome expressed in terms of time trade-off

Overall trial start date

01/06/2005

Overall trial end date

31/05/2011

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Patients admitted to hospital with severe ulcerative colitis, who have been treated with intravenous corticosteroids for between 48 hours and 5 days, and still fulfil Truelove and Witts criteria for severe colitis.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280

Participant exclusion criteria

1. Positive stool culture for enteric pathogens or Clostridium difficile
2. Cholesterol level below 3 mM
3. Greater than 5 days treatment with intravenous corticosteroids
4. Crohn's disease
5. Bowel perforation, or obstructive symptoms not due substantially to active inflammation
6. Pregnancy or lactation, or inability to take contraception during the trial
7. Treatment with ciclosporin tacrolimus or infliximab in the three months prior to study entry
8. Serious intercurrent infection or other active disease within three months prior to treatment
9. History of concurrent malignancy, or evidence of colonic dysplasia
10. Known human immunodeficiency virus (HIV) infection
11. Toxic dilation of the colon or clinical condition where colectomy is highly likely
12. Significant renal impairment (serum creatinine above 130 uM)
13. Uncontrolled hypertension

Recruitment start date

01/06/2005

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Digestive Diseases Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Support & Commercialisation Office
University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals UK Ltd (UK) - unconditional block grant (ref: COLO400A 2423)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes