A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Completed · Phase 2
Conditions studied: Constipation
In brief
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Key facts
- Study ID
- NCT00583154
- Run by
- Braintree Laboratories
- People needed
- 60
- Starts
- 2007-10-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2009-09-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Anaheim, California, United States
- Study site — Cranston, Rhode Island, United States
- Study site — Cumberland, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.