A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: BLI-801

• Registration Number: NCT00583154
• Lead Sponsor: Braintree Laboratories

Brief Summary

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-28
• Study First Posted: 2007-12-31
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2009-09
• Disposition First Submitted: 2009-09-24
• Disposition First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Disposition First Posted: 2009-09-28
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BLI-801	BLI-801 Dose 1
2	BLI-801	BLI-801 Dose 2
3	BLI-801	BLI-801 Dose 3
4	BLI-801	BLI-801 Dose 4

Primary Outcome Measures

Name	Time	Method
Bowel Movement Count	24 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 hours