A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
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Complete Spontaneous Bowel Movement (CSBM) [ Time Frame: 12 weeks ]
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)