A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

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

Official Title
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A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Conditions
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Chronic Idiopathic Constipation

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


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: A. 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 B. Loose stools are rarely present without the use of laxatives C. There are insufficient criteria for IBS - loose (mushy) or watery stool in the absence of laxative use for more than 25% of bowel movements Criteria A, B and C must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. 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 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 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 Visit 5 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 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 Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI400 Laxative<br>21 gm BLI400 powder | Drug: BLI400 Laxative<br>* 21 gm BLI400 powder<br>|
| Active Comparator: Lubiprostone<br>24 mcg capsule bid | Drug: Lubiprostone<br>* 24 mcg capsule bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Spontaneous Bowel Movement (CSBM) Response | The primary endpoint is based on the number 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 |