The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Olorinab active treatment for 8 weeks.
Clinical Research of Brandon
Brandon, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Hassman Research Institute
Berlin, New Jersey, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE was defined as an adverse event (AE) that occurred after first dose of olorinab. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events. Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time frame: Up to approximately 12 weeks
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Wake Research Associates
Raleigh, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States