Constipation
Conditions
Brief summary
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.
Interventions
DRUGBLI801 laxative - low dose
BLI801 laxative - oral solution
DRUGBLI801 laxative - high dose
BLI801 laxative - oral solution
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female subjects at least 18 years of age Constipated, defined by ROME definition: Otherwise in good health, as determined by physical exam and medical history
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 currently 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 | Description |
|---|---|---|
| Treatment Success | 4 weeks | percent of patients experiencing a response in 3 out of 4 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| serum chemistry | 4 weeks |
Countries
United States
Outcome results
None listed