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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Cathartics; Laxatives

Criteria

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