BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Condition: Constipation; Chronic Idiopathic Constipation; CIC
MeSH terms: Constipation
Intervention: BLI400 Laxative; BLI400 Placebo
Intervention description: 21 gm BLI400 powder; Equivalent amount of placebo powder
Intervention MeSH terms: Laxatives
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1020.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and
      efficacy versus placebo in constipated adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects at least 18 years of age

          2. Constipated, defined by the following adapted ROME II definition

             Fewer than 3 spontaneous defecations per week and at least one of the following
             symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12
             months:

               -  Straining during > 25% of defecations

               -  Lumpy or hard stools in > 25% of defecations

               -  Sensation of incomplete evacuation for > 25% of defecations

          3. If female, and of child-bearing potential, is using an acceptable form of birth
             control

          4. Negative serum pregnancy test at screening, if applicable

          5. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        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