A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
1 other identifier
interventional
81
1 country
4
Brief Summary
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses 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 Aug 2012
Shorter than P25 for phase_2
4 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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 16, 2014
July 1, 2014
7 months
September 14, 2012
July 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Success
percent of patients experiencing a response in 3 out of 4 weeks of treatment
4 weeks
Secondary Outcomes (1)
serum chemistry
4 weeks
Study Arms (2)
BLI801 laxative - low dose
EXPERIMENTALBLI801 laxative - oral solution
BLI801 laxative - high dose
EXPERIMENTALBLI801 laxative - oral solution
Interventions
BLI801 laxative - oral solution
Eligibility Criteria
You may qualify if:
- 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
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Clinsearch
Chattanooga, Tennessee, 37421, United States
Memphis Gastroenterology
Germantown, Tennessee, 38138, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John McGowan, MPH
Braintree Laboratories, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 19, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 16, 2014
Record last verified: 2014-07