A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Drug: BLI400 Laxative
- Registration Number
- NCT02481947
- Lead Sponsor
- Braintree Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 459
- 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:
- Straining during > 25% of defecations
- Lumpy or hard stools in > 25% of defecations
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BLI400 Laxative BLI400 Laxative 21 gm BLI400 powder Lubiprostone Lubiprostone 24 mcg capsule bid
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
BLI Research Site 12
🇺🇸Artesia, California, United States
BLI Research Site 13
🇺🇸Laguna Hills, California, United States
BLI Research Site 47
🇺🇸Owensboro, Kentucky, United States
BLI Research Site 5
🇺🇸Miami, Florida, United States
BLI Research Site 36
🇺🇸Miami, Florida, United States
BLI Research Site 8
🇺🇸Miami, Florida, United States
BLI Research Site 7
🇺🇸Atlanta, Georgia, United States
BLI Research Site 16
🇺🇸Chicago, Illinois, United States
BLI Research Site 23
🇺🇸San Diego, California, United States
BLI Research Site 49
🇺🇸Las Vegas, Nevada, United States
BLI Research Site 14
🇺🇸Cincinnati, Ohio, United States
BLI Research Site 21
🇺🇸Tucson, Arizona, United States
BLI Research Site 19
🇺🇸Nashville, Tennessee, United States
BLI Research Site 38
🇺🇸Mobile, Alabama, United States
BLI Research Site 41
🇺🇸Orange, California, United States
BLI Research Site 4
🇺🇸Brandon, Florida, United States
BLI Research Site 10
🇺🇸Anaheim, California, United States
BLI Research Site 30
🇺🇸La Mirada, California, United States
BLI Research Site 33
🇺🇸Richland, Washington, United States
BLI Research Site 34
🇺🇸Miami, Florida, United States
BLI Research Site 27
🇺🇸New York, New York, United States
BLI Research Site 46
🇺🇸DeLand, Florida, United States
BLI Research Site 2
🇺🇸Plano, Texas, United States
BLI Research Site 22
🇺🇸Chattanooga, Tennessee, United States
BLI Research Site 29
🇺🇸Knoxville, Tennessee, United States
BLI Research Site 42
🇺🇸Carrollton, Texas, United States
BLI Research Site 45
🇺🇸Memphis, Tennessee, United States
BLI Research Site 35
🇺🇸Charlottesville, Virginia, United States
BLI Research Site 3
🇺🇸Tampa, Florida, United States
BLI Research Site 44
🇺🇸Clearwater, Florida, United States
BLI Research Site 40
🇺🇸Hialeah, Florida, United States
BLI Research Site 17
🇺🇸Miami Lakes, Florida, United States
BLI Research Site 24
🇺🇸Saint Petersburg, Florida, United States
BLI Research Site 15
🇺🇸Newport News, Virginia, United States
BLI Research Site 48
🇺🇸Channelview, Texas, United States
BLI Research Site 50
🇺🇸Sacramento, California, United States
BLI Research Site 18
🇺🇸Orlando, Florida, United States
BLI Research Site 28
🇺🇸Corona, California, United States
BLI Research Site 26
🇺🇸Brandon, Florida, United States
BLI Research Site 32
🇺🇸Hialeah, Florida, United States
BLI Research Site 43
🇺🇸Miami Springs, Florida, United States
BLI Research Site 37
🇺🇸Palmetto Bay, Florida, United States
BLI Research Site 1
🇺🇸West Palm Beach, Florida, United States
BLI Research Site 11
🇺🇸Orlando, Florida, United States
BLI Research Site 6
🇺🇸Monroe, Louisiana, United States
BLI Research Site 25
🇺🇸Snellville, Georgia, United States
BLI Research Site 39
🇺🇸Raleigh, North Carolina, United States
BLI Research Site 31
🇺🇸West Monroe, Louisiana, United States
BLI Research Site 20
🇺🇸Austin, Texas, United States
BLI Research Site 9
🇺🇸Austin, Texas, United States