NCT03155945.

Methods	Study design: RCT Setting: NS
Participants	14 adults
Interventions	IG: APD371 low‐dose treatment CG: APD371 high‐dose treatment
Outcomes	Starting date: 18 May 2018 Actual completion date: 5 September 2018 Outcomes: Primary Number of participants with adverse events and abnormal clinical laboratory tests (including haematology, serum chemistry, coagulation, and urinalysis) [ Time Frame: up to 8 weeks ] Tolerability and safety of 2 doses of APD371 in people with Crohn's disease experiencing abdominal pain. Secondary Change in peak plasma concentration (Cmax) [ Time Frame: up to 8 weeks ] Change in time to Cmax (Tmax) [ Time Frame: up to 8 weeks ] Change in area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 8 weeks ] Change in abdominal pain score (APS) [ Time Frame: up to 8 weeks ] From pre‐dose (trough) to 1.5 h postdose (peak) following the first of 3 daily doses of APD371; assessed daily to Day 56. Change in average APS (AAPS) [ Time Frame: up to 8 weeks ] From screening and averaged weekly to Week 8. Proportion of participants who were end‐of‐treatment responders [ Time Frame: up to 8 weeks ] Proportion of participants who were weekly responders [ Time Frame: up to 8 weeks ] Number of pain‐free days per week in each treatment cohort, based on responses to the APS [ Time Frame: up to 8 weeks ] Frequency of pain rescue medication use in each treatment cohort [ Time Frame: up to 8 weeks ] Effect of APD371 treatment on reduction in CRP levels at Week 4 and Week 8 [ Time Frame: up to 8 weeks ] Effect of APD371 treatment on reduction in faecal calprotectin levels at Week 4 and Week 8 [ Time Frame: up to 8 weeks ]
Notes	Funding: Arena Pharmaceuticals Contact: ct.gov@arenapharm.com The sponsor is unable to provide any information beyond what is already in the public domain. Insufficient information to determine whether this study meets our inclusion criteria.