The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
190
A3309 in three different dosage levels or placebo once daily for the duration of the study
Change From Baseline in Frequency of Spontaneous Bowel Movements
Primary ep W 1
Time frame: Baseline, weekly, up to 8 weeks
Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)
A CSBM responder is defined as per FDA draft guidance for IBS-C: An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment
Time frame: Baseline, weekly and up to 8 weeks
Time to First Bowel Movement
Time frame: First week
Stool Consistency Change From Baseline
Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.
Time frame: Baseline, weekly and up to 8 weeks
LDL/HDL Ratio
Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted
Time frame: Baseline and 8 weeks of treatment
Straining Change From Baseline
Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.
Time frame: Baseline and during 8 weeks of treatment
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