A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: BLI400 Laxative; Lubiprostone
Intervention description: 21 gm BLI400 powder; 24 mcg capsule bid
Intervention MeSH terms: Laxatives; Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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:

          1. Straining during > 25% of defecations

          2. Lumpy or hard stools in > 25% of defecations

          3. 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)