A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adolescent Subjects

NCT ID: NCT02665728

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-04-30

Brief Summary

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

Conditions

Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BLI400

BLI400 Laxative

Group Type: EXPERIMENTAL

BLI400 Laxative

Intervention Type: DRUG

Interventions

BLI400 Laxative

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

BLI Research Site 1

Miami, Florida, United States

BLI Research Site 2

Palmetto Bay, Florida, United States

BLI Research Site 3

Richland, Washington, United States

Countries

United States

Other Identifiers

BLI400-201

Identifier Type: -

Identifier Source: org_study_id