A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
1 other identifier
interventional
60
1 country
3
Brief Summary
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedSeptember 28, 2009
September 1, 2009
3 months
December 20, 2007
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bowel Movement Count
24 hours
Secondary Outcomes (1)
Adverse events
24 hours
Study Arms (4)
1
EXPERIMENTALBLI-801 Dose 1
2
EXPERIMENTALBLI-801 Dose 2
3
EXPERIMENTALBLI-801 Dose 3
4
EXPERIMENTALBLI-801 Dose 4
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Anaheim, California, United States
Unknown Facility
Cranston, Rhode Island, United States
Unknown Facility
Cumberland, Rhode Island, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John McGowan
Braintree Laboratories, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 31, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2008
Study Completion
April 1, 2008
Last Updated
September 28, 2009
Record last verified: 2009-09