Condition category
Digestive System
Date applied
24/08/2006
Date assigned
13/09/2006
Last edited
07/04/2015
Prospective/Retrospective
Prospectively 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 Stephen Tsao

ORCID ID

Contact details

Digestive Diseases Centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
+44 (0)116 254 1414
tsao.stephen@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Epidermal growth factor enema versus mesalazine enema for the treatment of mild-to-moderate active left-sided ulcerative colitis

Acronym

Study hypothesis

Epidermal Growth Factor (EGF) is as effective as mesalazine in the treatment of mild-to-moderately active left-sided Ulcerative Colitis (UC).

Ethics approval

Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 – approval pending

Study design

Interventional randomised double-blind case-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Left-sided ulcerative colitis

Intervention

Group 1: Patients will receive a two week course of EGF enema
Group 2: Patients will receive a two week course of mesalazine enema.

Participants will be randomly assigned into either group and all parties involved will be blinded until the end of the follow-up period.

Intervention type

Drug

Phase

Not Applicable

Drug names

Epidermal growth factor enema, mesalazine enema

Primary outcome measures

Remission at week two as determined by a UC-DAI score of less than two.

Secondary outcome measures

1. Remission at week four as determined by a UC-DAI score of less than two
2. Improvements in UC-DAI score by more than two points from baseline at week two and week four
3. Improvements in Histological-DAI score by more than two points from baseline at week two and week four

Overall trial start date

01/10/2006

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females aged above 18 with a definite diagnosis of UC or proctitis
2. Mild-to-moderate disease activity with a UC Disease Activity Index (UC-DAI) score between three and eight

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients with infectious colitis
2. Colonic inflammation extending proximal to the left colon (i.e. beyond the splenic flexure on sigmoidoscopic examination)
3. Patients receiving oral maintenance therapy with a total daily dose of more than 3 g of mesalazine within 30 days prior to study entry
4. Use of any immunosuppressive agent within 90 days prior to the study
5. Intake of corticosteroids (orally or rectally) within seven days prior to entry
6. Chronic use of non-steroidal anti-inflammatory drugs in seven days prior to inclusion (chronic use defined as drug intake for a minimum of seven consecutive days)
7. Presence of severe renal/hepatic impairment, malignant disease and
allergies to salicylates

Recruitment start date

01/10/2006

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom
+44 (0)116 258 4199
djr8@le.ac.uk

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Broad Medical Research Program, the Eli and Edythe L. Broad Foundation (IBD-0172R)

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