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

ISRCTN	ISRCTN48675191
DOI	https://doi.org/10.1186/ISRCTN48675191
Secondary identifying numbers	N/A

Submission date: 24/08/2006
Registration date: 13/09/2006
Last edited: 11/07/2017

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 Stephen Tsao
Scientific

Digestive Diseases Centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Phone	+44 (0)116 254 1414
Email	tsao.stephen@gmail.com

Study information

Study design	Interventional randomised double-blind case-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Epidermal growth factor enema versus mesalazine enema for the treatment of mild-to-moderate active left-sided ulcerative colitis
Study objectives	Epidermal Growth Factor (EGF) is as effective as mesalazine in the treatment of mild-to-moderately active left-sided Ulcerative Colitis (UC).
Ethics approval(s)	Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 – approval pending
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/10/2006
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Leicester Royal Infirmary

Leicester
LE1 5WW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom

Phone	+44 (0)116 258 4199
Email	djr8@le.ac.uk
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/07/2017: No publications found, verifying study status with principal investigator.