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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583154
• Other study ID #: BLI-801-101
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: September 24, 2009
• Start date: October 2007
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• BLI-801
Dose 1
• BLI-801
Dose 2
• BLI-801
Dose 3
• BLI-801
Dose 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Movement Count		24 hours	No
Secondary	Adverse events		24 hours	Yes