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 |
| Protocol serial number | N/A |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | Broad Medical Research Program, the Eli and Edythe L. Broad Foundation (IBD-0172R) |
- 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
Scientific
Digestive Diseases Centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
| Phone | +44 (0)116 254 1414 |
|---|---|
| tsao.stephen@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised double-blind case-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Epidermal growth factor, mesalazine |
| Primary outcome measure(s) |
Remission at week two as determined by a UC-DAI score of less than two |
| Key secondary outcome measure(s) |
1. Remission at week four as determined by a UC-DAI score of less than two |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2017: No publications found, verifying study status with principal investigator.
