A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.
- Conditions
- Moderate acute ulcerative colitis.
- Registration Number
- EUCTR2004-005032-35-DK
- Lead Sponsor
- Alizyme Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 890
Patients fulfilling the following criteria are eligible for participation in the study:
1) Male and female patients aged 18-75.
2) Endoscopically confirmed diagnosis of ulcerative colitis extending more than 15 cm from the anal margin.
3) Score of 6 10 on the DAI (see Section 7.10.1 for definition).
4) Moderate to severe mucosal appearance score of 2 or 3 on sigmoidoscopy, see Section 7.10.1.
5) Patients must be able to adhere to the study visit schedule and other protocol requirements.
6) Patients must understand and voluntarily sign informed consent.
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
Patients who meet any of the following criteria are to be excluded from study participation:
1) Patients who have had previous colonic surgery.
2) Female patients of childbearing potential who are not willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partner.
3) Pregnant or breast-feeding females.
4) Use of oral corticosteroids in the last 3 days prior to screening sigmoidoscopy or for more than 3 days in the last 2 weeks prior to randomisation. No oral steroid treatment to be given between screening and randomisation.
5) Known hypersensitivity to steroids.
6) Use of topical (enema) corticosteroids or topical (enema) 5 ASA therapy for more than 3 days in the last 2 weeks prior to randomisation. No topical steroid or topical 5 ASA treatment to be given between screening and randomisation.
7) Patients taking 5-ASA therapy at a dose that has not been stable for at least 2 weeks prior to randomisation. (Patients relapsing on 5 ASA therapy who have been maintained on stable 5-ASA therapy for at least 2 weeks prior to randomisation must remain on the dose at which they have been stabilised for the duration of the study.)
8) Patients receiving immunosuppressive therapy, except those patients who have been maintained on immunosuppressive treatment for at least 3 months, and whose dose of immunosuppressant has remained stable for the 2 weeks prior to randomisation. These patients must remain on the dose at which they have been stabilised for the duration of the study.
9) Use of oral or parenteral antibiotics within 14 days prior to randomisation.
10) Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis.
11) Clinically significant established diagnosis of diabetes, heart failure, unstable angina, cirrhosis or renal failure (creatinine =150 µmol/L).
12) Established diagnosis of Crohn’s disease.
13) History of tuberculosis.
14) Documented human immunodeficiency virus (HIV) infection.
15) Current known malignancy or history of malignancy, which places patient at unacceptable risk for participation or may decrease life expectancy.
16) History of alcohol or drug abuse.
17) Any condition which in the opinion of the Investigator would place the patient at an unacceptable risk if participation in the study proceeded.
18) Participation in a previous clinical trial of an investigational (unapproved) product within 3 months prior to randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Main Objective: The objective of this study is to compare safety and efficacy of COLAL PRED® with prednisolone in patients diagnosed with moderate acute ulcerative colitis by the following:<br>• To determine the optimum dose, i.e. the dose that demonstrates non-inferiority to conventional prednisolone in terms of efficacy, with a significant reduction or absence of steroid-related adverse effects;<br>• To investigate the clinical differences in response between 40, 60 and 80 mg of COLAL PRED® in terms of safety and efficacy.<br>;Primary end point(s): The primary efficacy endpoint will be Clinical Improvement defined by the Disease Activity Index and the primary safety endpoint will be defined by early morning plasma cortisol. The co primary analyses will be non-inferior efficacy in comparison with conventional prednisolone and superior safety in comparison with conventional prednisolone.
- Secondary Outcome Measures
Name Time Method