Chronic Idiopathic Constipation
Conditions
Brief summary
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
Interventions
DRUGBLI400 Laxative
21 gm BLI400 powder
DRUGLubiprostone
24 mcg capsule bid
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 18 years of age * Constipated, defined by the following adapted ROME II definition: A. 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 B. Loose stools are rarely present without the use of laxatives C. There are insufficient criteria for IBS - 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 3 months 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 * 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 5 * 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 any study medication component * Subjects taking narcotic analgesics or other medications known to cause constipation * Subjects with clinically significant cardiac abnormalities identified at the Visit 1 ECG * 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 * Subjects with known or suspected moderate to severe hepatic insufficiency (Child Pugh Classes B and C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Spontaneous Bowel Movement (CSBM) Response | 12 weeks | The primary endpoint is based on the number of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI400 Laxative BLI400 Laxative
BLI400 Laxative: Oral laxative | 230 |
| Lubiprostone Lubiprostone
Lubiprostone: Oral laxative | 229 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 11 |
| Overall Study | Lost to Follow-up | 11 | 5 |
| Overall Study | Physician Decision | 4 | 5 |
| Overall Study | Protocol Violation | 1 | 5 |
| Overall Study | Withdrawal by Subject | 24 | 10 |
Baseline characteristics
| Characteristic | BLI400 Laxative | Total | Lubiprostone |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 13.6 | 45.5 years STANDARD_DEVIATION 14.1 | 45.6 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 95 Participants | 193 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 266 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 63 Participants | 131 Participants | 68 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) White | 156 Participants | 302 Participants | 146 Participants |
| Region of Enrollment United States | 230 participants | 459 participants | 229 participants |
| Sex: Female, Male Female | 187 Participants | 366 Participants | 179 Participants |
| Sex: Female, Male Male | 43 Participants | 93 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 225 | 0 / 229 |
| other Total, other adverse events | 26 / 225 | 15 / 229 |
| serious Total, serious adverse events | 2 / 225 | 1 / 229 |
Outcome results
Primary
Complete Spontaneous Bowel Movement (CSBM) Response
The primary endpoint is based on the number of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of \> 1 CSBM in that week.
Time frame: 12 weeks
Population: Per-protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI400 Laxative | Complete Spontaneous Bowel Movement (CSBM) Response | 47 Participants |
| Lubiprostone | Complete Spontaneous Bowel Movement (CSBM) Response | 56 Participants |
p-value: 0.016Chi-squared