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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2006-002036-25-GB
• Date of registration: 15/02/2012
• Prospective Registration: No
• Primary sponsor: University Hospitals of Leicester NHS Trust
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 09/11/2006
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002036-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Product Name: Epidermal growth factor enema
Product Code: EGF enema
Pharmaceutical Form: Enema
INN or Proposed INN: Epidermal growth factor
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Pentasa enema
Product Name: Pentasa
Pharmaceutical Form: Enema
INN or Proposed INN: mesalazine enema
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Secondary Objective:

Main Objective: To determine the efficacy of EGF enema in the treatment of acute left-sided ulcerative colitis compared with that of mesalazine enema.

Primary end point(s): Ulcerative colitis clinical remission at week-2 with a Ulcerative Colitis Disease Activity Index score of less than 2.

Secondary ID(s)

version1

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 03/05/2019
• Date Completed: 21/06/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-002036-25/results