BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults
NCT ID: NCT02819297
Last Updated: 2020-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1020 participants
INTERVENTIONAL
2016-06-30
2017-06-30
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
QUADRUPLE
Study Groups
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BLI400 Laxative
BLI400 Laxative
BLI400 Laxative
21 gm BLI400 powder
Placebo
BLI400 placebo
BLI400 Placebo
Equivalent amount of placebo powder
Interventions
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BLI400 Laxative
21 gm BLI400 powder
BLI400 Placebo
Equivalent amount of placebo powder
Eligibility Criteria
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Inclusion Criteria
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
4. Negative serum 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
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 the study
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 study medication 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
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
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
Role: STUDY_DIRECTOR
Braintree Laboratories, Inc.
Locations
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Braintree Research Site 8
Birmingham, Alabama, United States
Braintree Research Site 47
Mobile, Alabama, United States
Braintree Research Site 28
Phoenix, Arizona, United States
Braintree Research Site 4
Little Rock, Arkansas, United States
Braintree Research Site 11
Anaheim, California, United States
Braintree Research Site 29
Corona, California, United States
Braintree Research Site 35
Garden Grove, California, United States
Braintree Research Site 32
La Mirada, California, United States
Braintree Research Site 50
Sacramento, California, United States
Braintree Research Site 51
Westminster, California, United States
Braintree Research Site 36
Denver, Colorado, United States
Braintree Research Site 45
Clearwater, Florida, United States
Braintree Research Site 10
Hialeah, Florida, United States
Braintree Research Site 37
Hialeah, Florida, United States
Braintree Research Site 39
Hialeah, Florida, United States
Braintree Research Site 2
Miami, Florida, United States
Braintree Research Site 6
Miami, Florida, United States
Braintree Research Site 38
Miami, Florida, United States
Braintree Research Site 52
Miami, Florida, United States
Braintree Research Site 19
Miami Lakes, Florida, United States
Braintree Research Site 44
Miami Springs, Florida, United States
Braintree Research Site 13
Orlando, Florida, United States
Braintree Research Site 43
Pembroke Pines, Florida, United States
Braintree Research Site 25
Tamarac, Florida, United States
Braintree Research Site 3
Tampa, Florida, United States
Braintree Research Site 1
West Palm Beach, Florida, United States
Braintree Research Site 41
Atlanta, Georgia, United States
Braintree Research Site 20
Marietta, Georgia, United States
Braintree Research Site 27
Snellville, Georgia, United States
Braintree Research Site 46
Meridian, Idaho, United States
Braintree Research Site 15
Chicago, Illinois, United States
Braintree Research Site 7
Bastrop, Louisiana, United States
Braintree Research Site 12
New Orleans, Louisiana, United States
Braintree Research Site 24
Las Vegas, Nevada, United States
Braintree Research Site 26
Brooklyn, New York, United States
Braintree Research Site 17
Hartsdale, New York, United States
Braintree Research Site 21
High Point, North Carolina, United States
Braintree Research Site 5
Raleigh, North Carolina, United States
Braintree Research Site 16
Cincinnati, Ohio, United States
Braintree Research Site 30
Cleveland, Ohio, United States
Braintree Research Site 48
Columbus, Ohio, United States
Braintree Research Site 9
Dayton, Ohio, United States
Braintree Research Site 18
Smithfield, Pennsylvania, United States
Braintree Research Site 23
Lancaster, South Carolina, United States
Braintree Research Site 22
Chattanooga, Tennessee, United States
Braintree Research Site 31
Knoxville, Tennessee, United States
Braintree Research Site 40
Houston, Texas, United States
Braintree Research Site 34
San Antonio, Texas, United States
Braintree Research Site 42
West Jordan, Utah, United States
Braintree Research Site 14
Newport News, Virginia, United States
Braintree Research Site 49
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BLI400-302
Identifier Type: -
Identifier Source: org_study_id
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