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 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, mesalazine
Primary outcome measure
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 (if study stopped)
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
Basic results (scientific)
Publication list