Olorinab
DrugOlorinab active treatment for 8 weeks.
Other names: APD371
NCT Number: NCT03155945
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Clinical Research of Brandon, Brandon, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: other protocol defined Inclusion/Exclusion criteria may apply.
Olorinab active treatment for 8 weeks.
Other names: APD371
Time frame: Up to approximately 12 weeks
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: Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
The result for this exploratory endpoint was not reported.
Time frame: Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
The result for this exploratory endpoint was not reported.
Time frame: Week 0 (Day 1, Day 2), Week 8 (Day -1), Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose
The result for this exploratory endpoint was not reported.
Time frame: Baseline; Week 8
The result for this exploratory endpoint was not reported.
Time frame: Baseline; Week 1, 2, 4, 6 and 8
The result for this exploratory endpoint was not reported.
Time frame: Week 8
The result for this exploratory endpoint was not reported.
Time frame: Weeks 1, 2, 4, 6, and 8
The result for this exploratory endpoint was not reported.
Time frame: Week 1, Week 2, Week 4, Week 6, Week 8, and end of treatment
The result for this exploratory endpoint was not reported.
Time frame: Up to Week 8
The result for this exploratory endpoint was not reported.
Time frame: Baseline, Week 4, Week 8
The result for this exploratory endpoint was not reported.
Time frame: Baseline, Week 4, Week 8
The result for this exploratory endpoint was not reported.
Arena Pharmaceuticals
Industry
A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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