The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,020
21 gm BLI400 powder
Equivalent amount of placebo powder
Treatment Response
The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
Time frame: 12 weeks
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Braintree Research Site 8
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Corona, California, United States
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Garden Grove, California, United States
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La Mirada, California, United States
Braintree Research Site 50
Sacramento, California, United States
Braintree Research Site 51
Westminster, California, United States
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