BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Exclusion Criteria

• •1. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1
• •2. Meet the Rome II criteria for Irritable Bowel Syndrome.
• •3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
• •4. Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
• •5. Subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of Visit 1
• •6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study
• •7. Subjects who are pregnant or lactating, or intend to become pregnant during the study
• •8. Subjects of childbearing potential who refuse a pregnancy test
• •9. Subjects who are allergic to any study medication component
• •10. Subjects taking narcotic analgesics or other medications known to cause constipation
• •11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG
• •12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator
• •13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
• •14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• •15. Subjects with an active history of drug or alcohol abuse
• •16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1
• •17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures