ISRCTN ISRCTN31531671
DOI https://doi.org/10.1186/ISRCTN31531671
Secondary identifying numbers N0278078802
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
06/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hugh Shepherd
Scientific

Winchester Gastrointestinal Unit
Winchester and Eastleigh Healthcare NHS Trust
Royal Hampshire County Hospital
Romsey Road
Winchester
SO22 5DG
United Kingdom

Phone +44 (0)1962 824498

Study information

Study designDouble-blind randomised placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesIs intravenous heparin of clinical benefit to patients with moderate to severe ulcerative colitis?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive System: Ulcerative colitis
InterventionIntravenous heparin vs placebo
Intervention typeOther
Primary outcome measureTime to remission and time to next relapse.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/1997
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients with known acute, moderate/severe ulcerative colitis, with a Powell-Tuck score ≥12 on relapse, requiring inpatient treatment with intravenous steroids
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/07/1997
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Winchester Gastrointestinal Unit
Winchester
SO22 5DG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Winchester and Eastleigh Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan