Ulcerative Colitis Clinical Trial
— PROTECT-1Official title:
Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
Verified date | February 2017 |
Source | Dr. Falk Pharma GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
Status | Terminated |
Enrollment | 468 |
Est. completion date | December 16, 2016 |
Est. primary completion date | November 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Established diagnosis of ulcerative colitis - Active ulcerative colitis disease extent = 15 cm - Active disease despite treatment with mesalamine Exclusion Criteria: - Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis, - Toxic megacolon or fulminant colitis - Colon resection - Evidence of infectious colitis - Celiac disease - Bleeding hemorrhoids - History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack - Any severe concomitant renal, endocrine, or psychiatric disorder - Any relevant known systemic disease - History of cancer in the last five years - Abnormal hepatic function or liver cirrhosis - Abnormal HbA1c at screening visit - Patients with known hypersensitivity to soy - Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP) - Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins - Treatment with other investigational drug - Existing or intended pregnancy or breast-feeding |
Country | Name | City | State |
---|---|---|---|
Germany | Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine | Frankfurt a.M. |
Lead Sponsor | Collaborator |
---|---|
Dr. Falk Pharma GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of clinical remission | 12 weeks | ||
Secondary | Rate of patients with clinical improvement | 12 weeks | ||
Secondary | Time to first resolution of symptoms | 12 weeks | ||
Secondary | Number of stools per week | 12 weeks | ||
Secondary | Number of days with urgency per week | 12 weeks | ||
Secondary | Rate of mucosal healing | 12 weeks | ||
Secondary | Rate of histologic remission | 12 weeks | ||
Secondary | Physician's global assessment at final visit | 12 weeks | ||
Secondary | Quality of life | 12 weeks |
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