Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hugh Shepherd

ORCID ID

Contact details

Winchester Gastrointestinal Unit
Winchester and Eastleigh Healthcare NHS Trust
Royal Hampshire County Hospital
Romsey Road
Winchester
SO22 5DG
United Kingdom
+44 (0)1962 824498

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0278078802

Study information

Scientific title

Acronym

Study hypothesis

Is intravenous heparin of clinical benefit to patients with moderate to severe ulcerative colitis?

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Digestive System: Ulcerative colitis

Intervention

Intravenous heparin vs placebo

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time to remission and time to next relapse.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1997

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with known acute, moderate/severe ulcerative colitis, with a Powell-Tuck score ≥12 on relapse, requiring inpatient treatment with intravenous steroids

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/1997

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Winchester Gastrointestinal Unit
Winchester
SO22 5DG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Winchester and Eastleigh Healthcare NHS Trust (UK)

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