Constipation
Conditions
Brief summary
A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.
Interventions
DRUGBLI801
BLI801 laxative - oral solution
DRUGPlacebo
BLI801 placebo - oral solution
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Constipated, defined by ROME III definition * Subject has \< 3 satisfactory BMs during the run-in period
Exclusion criteria
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon * Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments. * Subjects who are allergic to any BLI801 component * Subjects taking narcotic analgesics or other medications known to cause constipation. * Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures * Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days * Subjects with an active history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose | 3 hours |
Secondary
| Measure | Time frame |
|---|---|
| percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose | 3 hours |
| serum chemistry | 7 days |
Countries
United States
Outcome results
None listed