Constipation
Conditions
Keywords
constipation, laxative
Brief summary
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Interventions
DRUGBLI-801
Dose 1
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 according to ROME I criteria * Otherwise in good health, as determined by physical exam and medical history * If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) * Negative urine 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
* 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 for the duration of the study * Subjects who are pregnant or lactating, or intending to become pregnant during the study * Subjects of childbearing potential who refuse a pregnancy test * Subjects who are allergic to any BLI-801 component. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel Movement Count | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | 24 hours |
Countries
United States
Outcome results
None listed