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

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

Conditions
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Constipation, Chronic Idiopathic Constipation, CIC

Intervention / Treatment
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* Drug: BLI400 Laxative
* Drug: BLI400 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects at least 18 years of age 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 If female, and of child-bearing potential, is using an acceptable form of birth control Negative serum 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: 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 Meet the Rome II criteria for Irritable Bowel Syndrome. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon 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 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 Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of the study Subjects who are pregnant or lactating, or intend to become pregnant during the study Subjects of childbearing potential who refuse a pregnancy test Subjects who are allergic to any study medication component Subjects taking narcotic analgesics or other medications known to cause constipation Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator 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 Subjects with an active history of drug or alcohol abuse Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1 Subjects who withdraw consent at any time prior to completion of Visit 1 procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI400 Laxative<br>BLI400 Laxative | Drug: BLI400 Laxative<br>* 21 gm BLI400 powder<br>|
| Placebo Comparator: Placebo<br>BLI400 placebo | Drug: BLI400 Placebo<br>* Equivalent amount of placebo powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of > 1 CSBM in that week. | 12 weeks |