A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
This trial has been completed.
|Start date||December 2015|
|End date||April 2016|
|Trial size||33 participants|
|Trial identifier||NCT02665728, BLI400-201|
The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 4 weeks
All participants from 12 years up to 17 years old.
Inclusion Criteria: - Male or female subjects at between 12-17 years of age - Weight more than 40 kg (88 lbs.). - Constipated, defined by the following criteria 1. 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 2. Loose stools are rarely present without the use of laxatives 3. There are insufficient criteria for irritable bowel syndrome - 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 12 weeks 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 (hormonal birth control, intrauterine device, double-barrier method, depot contraceptive, sterilized, or abstinence) - 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 3 - 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 the study medication - Subjects taking narcotic analgesics or other medications known to cause constipation - 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
|Official title||A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects|
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