Abdominal Pain, Diarrhea, Large Intestine, Ulcerative Colitis
Conditions
Brief summary
The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.
Interventions
DRUGLT-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
DRUGplacebo
placebo
Sponsors
Lipid Therapeutics GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women 18 years or older who have given written Informed Consent * Patients with proven ulcerative colitis * Active disease course for the last 6 weeks or longer with bloody diarrhea * Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.
Exclusion criteria
* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis, * Crohn's disease, * Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis, * Treatment with other investigational medicinal product within 3 months prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis | From day 1 of treatment until end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis | After study is completed |
Countries
Germany, Lithuania, Romania
Outcome results
None listed