Chronic Idiopathic Constipation, CIC, Constipation
Conditions
Brief summary
The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.
Interventions
DRUGBLI400 Laxative
oral laxative
Sponsors
Braintree Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects at least 18 years of age 2. Constipated, defined by the following adapted ROME II definition: * 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 3. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) 4. Negative urine pregnancy test at screening, if applicable 5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion criteria
1. Report loose (mushy) or water stools in the absence of laxative use for more than 25% of BMs during the 12 weeks before Visit 1 2. Meet the Rome II criteria for Irritable Bowel Syndrome 3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon 4. 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 5. 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 6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from Visit 1 until after completion of Visit 6 7. Subjects who are pregnant or lactating, or intend to become pregnant during the study 8. Subjects of childbearing potential who refuse a pregnancy test 9. Subjects who are allergic to any BLI400 component 10. Subjects taking narcotic analgesics or other medications known to cause constipation. 11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG 12. Subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the Investigator, may be discontinued at the Investigator's discretion. 13. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures 14. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days 15. Subjects with an active history of drug or alcohol abuse 16. Subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before Visit 1 17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of Subjects With Treatment Emergent Adverse Events | 12 months | % of subjects experiencing a treatment emergent adverse event during the 12 month treatment period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI400 Laxative BLI400 Laxative
BLI400 Laxative: oral laxative | 305 |
| Total | 305 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Physician Decision | 8 |
| Overall Study | Protocol Violation | 30 |
| Overall Study | Withdrawal by Subject | 37 |
Baseline characteristics
| Characteristic | BLI400 Laxative |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 133 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 91 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 205 Participants |
| Region of Enrollment United States | 305 participants |
| Sex: Female, Male Female | 223 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 305 |
| other Total, other adverse events | 34 / 305 |
| serious Total, serious adverse events | 2 / 305 |
Outcome results
Primary
% of Subjects With Treatment Emergent Adverse Events
% of subjects experiencing a treatment emergent adverse event during the 12 month treatment period
Time frame: 12 months
Population: FDA agreed upon Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI400 Laxative | % of Subjects With Treatment Emergent Adverse Events | 108 Participants |