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

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: BLI400 Laxative

• Registration Number: NCT02665728
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Disposition First Submitted: 2017-07-25
• Disposition First Submitted QC: 2017-07-25
• Disposition First Posted: 2017-07-27
• Status Verified: 2020-06
• Results First Submitted: 2020-06-09
• Results First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Results First Posted: 2020-06-26
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BLI400	BLI400 Laxative	BLI400 Laxative

Primary Outcome Measures

Name	Time	Method
Treatment Response	4 weeks	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.

Trial Locations

Locations (3)

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