Clinical trial NCT02665728: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
Official title: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Response
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: BLI Research Site 1
state: Florida
city: Palmetto Bay
country: United States
facility: BLI Research Site 2
state: Florida
city: Richland
country: United States
facility: BLI Research Site 3
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: