A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
NCT ID: NCT02822508
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
434 participants
INTERVENTIONAL
2016-06-30
2017-04-30
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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BLI801 Laxative (high dose)
BLI801 Laxative (high dose)
BLI801 Laxative
BLI801 oral laxative
BLI801 Laxative (mid dose)
BLI801 Laxative (mid dose)
BLI801 Laxative
BLI801 oral laxative
BLI801 Laxative (low dose)
BLI801 Laxative (low dose)
BLI801 Laxative
BLI801 oral laxative
BLI801 Placebo
BLI801 Placebo
BLI801 Placebo
BLI801 oral laxative placebo
Interventions
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BLI801 Laxative
BLI801 oral laxative
BLI801 Placebo
BLI801 oral laxative placebo
Eligibility Criteria
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Inclusion Criteria
2. Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
* Straining during \> 25% of defecations
* Lumpy or hard stools in \> 25% of defecations
* Sensation of incomplete evacuation for \> 25% of defecations
3. Receiving a stable maintenance opioid regimen.
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative pregnancy test at screening (Visit 1), if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria
2. Subjects who have had major surgery within 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
3. Medical conditions associated with diarrhea, intermittent loose stools or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
1. Absence of a structural or biochemical explanation for the abdominal pain symptom
2. At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
i. Relieved with defecation, and/or ii. Onset associated with a change in frequency of stool, and/or iii. Onset associated with a change in form of stool.
4. Subjects diagnosed with chronic constipation prior to initiation of opioid treatment
5. Subjects taking laxatives (with the exception of fiber supplements), prokinetic agents or antidiarrheal drugs and refuse to discontinue these treatments from Visit 1 until after completion of Visit 5
6. Subjects who are pregnant or nursing, or intend to become pregnant during the study
7. Subjects of childbearing potential who refuse a pregnancy test
8. Subjects who are allergic to any BLI801 component
9. Subjects taking non-opioid medications or supplements known to cause constipation
10. Subjects with an active history of drug or alcohol abuse
11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
12. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
13. Subjects who have had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
14. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
18 Years
84 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 43
Birmingham, Alabama, United States
Braintree Research Site 30
Peoria, Arizona, United States
Braintree Research Site 40
Phoenix, Arizona, United States
Braintree Research Site 52
Phoenix, Arizona, United States
Braintree Research Site 26
Phoenix, Arizona, United States
Braintree Research Site 56
Fayetteville, Arkansas, United States
Braintree Research Site 4
Little Rock, Arkansas, United States
Braintree Research Site 51
Anaheim, California, United States
Braintree Research Site 54
Fountain Valley, California, United States
Braintree Research Site 8
Fresno, California, United States
Braintree Research Site 71
Long Beach, California, United States
Braintree Research Site 74
Oceanside, California, United States
Braintree Research Site 59
Sacramento, California, United States
Braintree Research Site 28
Sacramento, California, United States
Braintree Research Site 68
Brooksville, Florida, United States
Braintree Research Site 36
Fort Myers, Florida, United States
Braintree Research Site 22
Homestead, Florida, United States
Braintree Research Site 5
Jacksonville, Florida, United States
Braintree Research Site 23
Jacksonville, Florida, United States
Braintree Research Site 63
Miami, Florida, United States
Braintree Research Site 29
Orlando, Florida, United States
Braintree Research Site 65
Orlando, Florida, United States
Braintree Research Site 13
Ormond Beach, Florida, United States
Braintree Research Site 20
St. Petersburg, Florida, United States
Braintree Research Site 39
St. Petersburg, Florida, United States
Braintree Research Site 31
Tampa, Florida, United States
Braintree Research Site 41
West Palm Beach, Florida, United States
Braintree Research Site 57
Blue Ridge, Georgia, United States
Braintree Research Site 48
Boise, Idaho, United States
Braintree Research Site 50
Evansville, Indiana, United States
Braintree Research Site 55
Lafayette, Indiana, United States
Braintree Research Site 38
Wichita, Kansas, United States
Braintree Research Site 64
Edgewood, Kentucky, United States
Braintree Research Site 73
Lake Charles, Louisiana, United States
Braintree Research Site 49
St Louis, Missouri, United States
Braintree Research Site 19
Omaha, Nebraska, United States
Braintree Research Site 21
Omaha, Nebraska, United States
Braintree Research Site 69
Henderson, Nevada, United States
Braintree Research Site 1
Las Vegas, Nevada, United States
Braintree Research Site 44
Las Vegas, Nevada, United States
Braintree Research Site 34
Las Vegas, Nevada, United States
Braintree Research Site 7
Belvidere, New Jersey, United States
Braintree Research Site 53
Trenton, New Jersey, United States
Braintree Research Site 10
Albuquerque, New Mexico, United States
Braintree Research Site 27
Brooklyn, New York, United States
Braintree Research Site 25
Great Neck, New York, United States
Braintree Research Site 61
Williamsville, New York, United States
Braintree Research Site 45
Greensboro, North Carolina, United States
Braintree Research Site 47
Winston-Salem, North Carolina, United States
Braintree Research Site 2
Beavercreek, Ohio, United States
Braintree Research Site 76
Cincinnati, Ohio, United States
Braintree Research Site 3
Columbus, Ohio, United States
Braintree Research Site 60
Columbus, Ohio, United States
Braintree Research Site 14
Huber Heights, Ohio, United States
Braintree Research Site 46
Oklahoma City, Oklahoma, United States
Braintree Research Site 16
Oklahoma City, Oklahoma, United States
Braintree Research Site 18
Lansdale, Pennsylvania, United States
Braintree Research Site 75
Charleston, South Carolina, United States
Braintree Research Site 17
Greer, South Carolina, United States
Braintree Research Site 42
Myrtle Beach, South Carolina, United States
Braintree Research Site 24
Spartanburg, South Carolina, United States
Braintree Research Site 72
Spartanburg, South Carolina, United States
Braintree Research Site 9
Summerville, South Carolina, United States
Braintree Research Site 37
Chattanooga, Tennessee, United States
Braintree Research Site 67
Tullahoma, Tennessee, United States
Braintree Research Site 11
Austin, Texas, United States
Braintree Research Site 33
Carrollton, Texas, United States
Braintree Research Site 62
Channelview, Texas, United States
Braintree Research Site 70
Houston, Texas, United States
Braintree Research Site 35
Salt Lake City, Utah, United States
Braintree Research Site 12
St. George, Utah, United States
Braintree Research Site 66
West Jordan, Utah, United States
Braintree Research Site 6
Tacoma, Washington, 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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BLI801-203
Identifier Type: -
Identifier Source: org_study_id
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