a safety and efficacy evaluation of bli400 laxative in constipated adults

Conditions: Chronic Idiopathic Constipation

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)