A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
NCT ID: NCT02481947
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
459 participants
INTERVENTIONAL
2015-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BLI400 Laxative
21 gm BLI400 powder
BLI400 Laxative
21 gm BLI400 powder
Lubiprostone
24 mcg capsule bid
Lubiprostone
24 mcg capsule bid
Interventions
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BLI400 Laxative
21 gm BLI400 powder
Lubiprostone
24 mcg capsule bid
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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John McGowan, MPH
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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BLI Research Site 38
Mobile, Alabama, United States
BLI Research Site 21
Tucson, Arizona, United States
BLI Research Site 10
Anaheim, California, United States
BLI Research Site 12
Artesia, California, United States
BLI Research Site 28
Corona, California, United States
BLI Research Site 30
La Mirada, California, United States
BLI Research Site 13
Laguna Hills, California, United States
BLI Research Site 41
Orange, California, United States
BLI Research Site 50
Sacramento, California, United States
BLI Research Site 23
San Diego, California, United States
BLI Research Site 26
Brandon, Florida, United States
BLI Research Site 4
Brandon, Florida, United States
BLI Research Site 44
Clearwater, Florida, United States
BLI Research Site 46
DeLand, Florida, United States
BLI Research Site 32
Hialeah, Florida, United States
BLI Research Site 40
Hialeah, Florida, United States
BLI Research Site 5
Miami, Florida, United States
BLI Research Site 34
Miami, Florida, United States
BLI Research Site 36
Miami, Florida, United States
BLI Research Site 8
Miami, Florida, United States
BLI Research Site 17
Miami Lakes, Florida, United States
BLI Research Site 43
Miami Springs, Florida, United States
BLI Research Site 11
Orlando, Florida, United States
BLI Research Site 18
Orlando, Florida, United States
BLI Research Site 37
Palmetto Bay, Florida, United States
BLI Research Site 24
St. Petersburg, Florida, United States
BLI Research Site 3
Tampa, Florida, United States
BLI Research Site 1
West Palm Beach, Florida, United States
BLI Research Site 7
Atlanta, Georgia, United States
BLI Research Site 25
Snellville, Georgia, United States
BLI Research Site 16
Chicago, Illinois, United States
BLI Research Site 47
Owensboro, Kentucky, United States
BLI Research Site 6
Monroe, Louisiana, United States
BLI Research Site 31
West Monroe, Louisiana, United States
BLI Research Site 49
Las Vegas, Nevada, United States
BLI Research Site 27
New York, New York, United States
BLI Research Site 39
Raleigh, North Carolina, United States
BLI Research Site 14
Cincinnati, Ohio, United States
BLI Research Site 22
Chattanooga, Tennessee, United States
BLI Research Site 29
Knoxville, Tennessee, United States
BLI Research Site 45
Memphis, Tennessee, United States
BLI Research Site 19
Nashville, Tennessee, United States
BLI Research Site 20
Austin, Texas, United States
BLI Research Site 9
Austin, Texas, United States
BLI Research Site 42
Carrollton, Texas, United States
BLI Research Site 48
Channelview, Texas, United States
BLI Research Site 2
Plano, Texas, United States
BLI Research Site 35
Charlottesville, Virginia, United States
BLI Research Site 15
Newport News, Virginia, United States
BLI Research Site 33
Richland, Washington, United States
Countries
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Other Identifiers
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BLI400-301
Identifier Type: -
Identifier Source: org_study_id
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