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The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI400 Laxative | Experimental | 21 gm BLI400 powder |
|
| Lubiprostone | Active Comparator | 24 mcg capsule bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI400 Laxative | Drug | 21 gm BLI400 powder |
| |
| Lubiprostone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BLI Research Site 38 | Mobile | Alabama | 36688 | United States | ||
| BLI Research Site 21 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI400 Laxative | BLI400 Laxative (21 gm BLI400 powder per day) |
| FG001 | Lubiprostone | Lubiprostone (24 mcg capsule bid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
24 mcg capsule bid |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| BLI Research Site 10 | Anaheim | California | 92801 | United States |
| BLI Research Site 12 | Artesia | California | 90701 | United States |
| BLI Research Site 28 | Corona | California | 92879 | United States |
| BLI Research Site 30 | La Mirada | California | 90638 | United States |
| BLI Research Site 13 | Laguna Hills | California | 92653 | United States |
| BLI Research Site 41 | Orange | California | 92868 | United States |
| BLI Research Site 50 | Sacramento | California | 95821 | United States |
| BLI Research Site 23 | San Diego | California | 92103 | United States |
| BLI Research Site 26 | Brandon | Florida | 33511 | United States |
| BLI Research Site 4 | Brandon | Florida | 33511 | United States |
| BLI Research Site 44 | Clearwater | Florida | 33756 | United States |
| BLI Research Site 46 | DeLand | Florida | 32720 | United States |
| BLI Research Site 32 | Hialeah | Florida | 33012 | United States |
| BLI Research Site 40 | Hialeah | Florida | 33012 | United States |
| BLI Research Site 5 | Miami | Florida | 33142 | United States |
| BLI Research Site 34 | Miami | Florida | 33144 | United States |
| BLI Research Site 36 | Miami | Florida | 33144 | United States |
| BLI Research Site 8 | Miami | Florida | 33144 | United States |
| BLI Research Site 17 | Miami Lakes | Florida | 33016 | United States |
| BLI Research Site 43 | Miami Springs | Florida | 33166 | United States |
| BLI Research Site 11 | Orlando | Florida | 32801 | United States |
| BLI Research Site 18 | Orlando | Florida | 32807 | United States |
| BLI Research Site 37 | Palmetto Bay | Florida | 33157 | United States |
| BLI Research Site 24 | St. Petersburg | Florida | 33709 | United States |
| BLI Research Site 3 | Tampa | Florida | 33607 | United States |
| BLI Research Site 1 | West Palm Beach | Florida | 33409 | United States |
| BLI Research Site 7 | Atlanta | Georgia | 30328 | United States |
| BLI Research Site 25 | Snellville | Georgia | 30078 | United States |
| BLI Research Site 16 | Chicago | Illinois | 60602 | United States |
| BLI Research Site 47 | Owensboro | Kentucky | 42303 | United States |
| BLI Research Site 6 | Monroe | Louisiana | 71201 | United States |
| BLI Research Site 31 | West Monroe | Louisiana | 71291 | United States |
| BLI Research Site 49 | Las Vegas | Nevada | 89103 | United States |
| BLI Research Site 27 | New York | New York | 10016 | United States |
| BLI Research Site 39 | Raleigh | North Carolina | 27609 | United States |
| BLI Research Site 14 | Cincinnati | Ohio | 45231 | United States |
| BLI Research Site 22 | Chattanooga | Tennessee | 37421 | United States |
| BLI Research Site 29 | Knoxville | Tennessee | 37938 | United States |
| BLI Research Site 45 | Memphis | Tennessee | 38119 | United States |
| BLI Research Site 19 | Nashville | Tennessee | 37012 | United States |
| BLI Research Site 20 | Austin | Texas | 78731 | United States |
| BLI Research Site 9 | Austin | Texas | 78735 | United States |
| BLI Research Site 42 | Carrollton | Texas | 75010 | United States |
| BLI Research Site 48 | Channelview | Texas | 77530 | United States |
| BLI Research Site 2 | Plano | Texas | 75024 | United States |
| BLI Research Site 35 | Charlottesville | Virginia | 22911 | United States |
| BLI Research Site 15 | Newport News | Virginia | 23606 | United States |
| BLI Research Site 33 | Richland | Washington | 99352 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI400 Laxative | BLI400 Laxative BLI400 Laxative: Oral laxative |
| BG001 | Lubiprostone | Lubiprostone Lubiprostone: Oral laxative |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-protocol population | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
12 weeks
Results for mortality, serious adverse events and other adverse events are based on the FDA agreed upon Safety Population (BLI400 n=225, lubiprostone n=229).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BLI400 Laxative | BLI400 Laxative (21 gm BLI400 powder) | 1 | 225 | 2 | 225 | 26 | 225 |
| EG001 | Lubiprostone | Lubiprostone (24 mcg capsule bid) | 0 | 229 | 1 | 229 | 15 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis of legs | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| stomach ulcer | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| flatulence | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Affairs | Braintree Laboratories, Inc. | 781-843-2202 | john.mcgowan@sebelapharma.com |
| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|