This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.
This is a Phase 2, Proof of Concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate Ulcerative Colitis. The study will consist of 3 phases: * Screening Phase - up to 4 weeks * Double-blind Placebo-controlled Phase - Weeks 0 to 8 * Follow-up Phase - Week 9
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 160 mg BID for 8 Weeks
Placebo BID for 8 Weeks
Efficacy on Ulcerative Colitis Disease Activity Index
After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated.
Time frame: up to 8 Weeks
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Clinical Applications Laboratories, Inc.
San Diego, California, United States
Center for Advanced Gastroenterology, PLLC
Maitland, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
IMIC, Inc
Palmetto Bay, Florida, United States
BRCR Medical Center, Inc
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Mount Sinai
New York, New York, United States
Penn State University Milton S. Hershey Medical Center
State College, Pennsylvania, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Cook Children's Medical Center
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Envision Clinical Research, LLC
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