Constipation
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.
Interventions
DRUGBLI400 Laxative
Sponsors
Braintree Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI400 BLI400 Laxative
BLI400 Laxative | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | BLI400 |
|---|---|
| Age, Continuous | 15.4 years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
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.
Time frame: 4 weeks
Population: Intent to Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI400 | Treatment Response | 32 Participants |