NCT00583154CompletedPhase 2
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Braintree Laboratories0 sites60 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Bowel Movement Count
Study Overview
Brief Summary
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
4
Experimental
BLI-801 Dose 4
Intervention: BLI-801 (Drug)
1
Experimental
BLI-801 Dose 1
Intervention: BLI-801 (Drug)
2
Experimental
BLI-801 Dose 2
Intervention: BLI-801 (Drug)
3
Experimental
BLI-801 Dose 3
Intervention: BLI-801 (Drug)
Outcomes
Primary Outcomes
Bowel Movement Count
Time Frame: 24 hours
Secondary Outcomes
- Adverse events(24 hours)
Investigators
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