Status and phase
Conditions
Treatments
About
The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects at least 18 years of age
Constipated, defined by the following adapted ROME II definition
Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months:
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative serum pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,020 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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