Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC

Phase 1

• Conditions: lcerative Colitis

• Registration Number: EUCTR2006-002036-25-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-06-21
• Study Start: 2012-02-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) male and female participants above age of 18 with a definite diagnosis of ulcerative colitis or proctitis.
2) mild-to-moderate disease activity with a UC disease activity index score between 3 and 8.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 >3g of mesalazine within 30days prior to study entry.
4) use of any immunosuppressive agent within 90days prior to study.
5) intake of corticosteroids (orally or rectally) within 7days prior to entry.
6) chronic use of non-steroidal anti-inflammatory drugs in 7 days prior to inclusion (chronic use defined as drug intake for a minimum of 7 consecutive days).
7) presence of severe renal / hepatic impairment, malignant disease and allergies to salicylates.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of EGF enema in the treatment of acute left-sided ulcerative colitis compared with that of mesalazine enema.;Secondary Objective: ;Primary end point(s): Ulcerative colitis clinical remission at week-2 with a Ulcerative Colitis Disease Activity Index score of less than 2.