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Biotech / Medical : Arena Pharmaceuticals (ARNA)
ARNA 99.990.0%Mar 15 5:00 PM EST
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To: Harold Engstrom who wrote (2270)4/20/2018 11:16:10 PM
From: Biotech Jim  Read Replies (1) of 2274
 
Sheesh, its an open label trial. How much can one read into that?

clinicaltrials.gov

Outcome Measures

Primary Outcome Measures :Number of patients with adverse events and abnormal clinical laboratory tests (including hematology, serum chemistry, coagulation and urinalysis). [ Time Frame: up to 8 weeks ]
Tolerability and safety of two doses of APD371 in subjects with Crohn's Disease experiencing abdominal pain

Secondary Outcome Measures :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 hr post-dose (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 subjects who are end-of-treatment responders [ Time Frame: up to 8 weeks ]
Proportion of subjects who are weekly responders [ Time Frame: up tp 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 C-reactive protein (CRP) levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]
Effect of APD371 treatment on reduction in fecal calprotectin levels at week 4 and week 8 [ Time Frame: up to 8 weeks ]

Curious, why not PBO controlled? Sounds like a Wall Street trial to me. And I heard one of the discussions.
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