Ulcerative Colitis
Conditions
Interventions
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: equa
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed