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

NCT02665728 | Completed Phase 2 Results

• 1 other identifier: BLI400-201
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  Overall treatment response is defined as weekly response in at least 2 out of 4 weeks. Weekly response is defined as greater than or equal to 3 spontaneous bowel movements during a week.

  4 weeks

Study Arms (1)

BLI400

EXPERIMENTAL

BLI400 Laxative

Drug: BLI400 Laxative

Interventions

BLI400 Laxative DRUG

BLI400

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects at between 12-17 years of age
• Weight more than 40 kg (88 lbs.).
• Constipated, defined by the following criteria
• 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
• Loose stools are rarely present without the use of laxatives
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (3)

BLI Research Site 1

Miami, Florida, 33142, United States

Location

BLI Research Site 2

Palmetto Bay, Florida, 33157, United States

Location

BLI Research Site 3

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President, Clinical Affairs
• Organization: Braintree Laboratories, Inc.

john.mcgowan@sebelapharma.com

781-843-2202

Study Officials

• John McGowan

  Braintree Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 26, 2020
• Results First Posted: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)