EUCTR2011-002462-20-HU
Active, not recruiting
Not Applicable
Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr August Wolff GmbH & Co KG Arzneimittel
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures.
- •2\. Adult males or females, aged 18 to 70 years (inclusive).
- •3\. Females of childbearing potential must have a negative urine pregnancy test at screening and must agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilisation or partner vasectomy, or doble barrier method) from screening visit until at least 4 weeks after last dose of study medication (Week 12\). A double barrier method means condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, cream of suppository.A female condom and a male condom should not be used together as friction between the two can result in either product failing.
- •4\. Females of non\-child bearing potential should be postmenopausal for \>1 year or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
- •5\. Male patients must agree to use adequate contraception (e.g. vasectomy or adequate partner contraception).
- •6\. Body mass index (BMI) \=19 and \=30 kg/m2\.
- •7\. Mild to moderately active UC proven by endoscopy and criteria according to European Crohn's and Colitis Organisation (ECCO) guidelines and defined as a CAI of 6 to 12\.
- •8\. Pre\-treatment of active ulcerative colitis with any of the following:
- •\- a stable dose of oral mesalazine, sulphasalazine or olsalazine for \>4 weeks (oral), and/or
- •\- a stable dose of azathioprine or 6\-mercaptopurin for \>3 months, and/or
Exclusion Criteria
- •1\. Pregnant, planning to become pregnant during the study, or breast feeding females.
- •2\. Previous participation in any clinical study with K(D)PT.
- •3\. Crohn’s disease.
- •4\. Treatment\-naive.
- •5\. Infectious diarrhoea within the screening period (up to 14 days prior the randomization visit (Visit 2\)), after randomization or during the treatment period.
- •6\. Indeterminate colitis.
- •7\. Significantly impaired liver, renal, pulmonary or cardiovascular function.
- •8\. Use of systemic or topical gastrointestinal antibiotics within 4 weeks before or during the treatment period(day 1\).
- •9\.Use of E. coli Nissle within 4 weeks before or during the treatment period.
- •10\. Previous use of cyclosporine, anti\-TNF therapy (e.g. infliximab) or tacrolimus at any time.
Outcomes
Primary Outcomes
Not specified
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