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The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI400 Laxative | Experimental | BLI400 Laxative |
|
| Placebo | Placebo Comparator | BLI400 placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI400 Laxative | Drug | 21 gm BLI400 powder |
| |
| BLI400 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response | The primary endpoint is the proportion 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:
Male or female subjects at least 18 years of age
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:
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative serum 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:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Braintree Research Site 8 | Birmingham | Alabama | 35216 | United States | ||
| Braintree Research Site 47 |
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1020 subjects were consented and entered into a two-week run-in period to confirm constipation status (subjects were required to average < 3 complete spontaneous bowel movements per week). Following the run-in period, 603 subjects qualified for randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI400 Laxative | BLI400 Laxative (21 gm of BLI400 powder) |
| FG001 | Placebo | BLI400 placebo (equivalent amount of placebo powder) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2016 |
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| Drug |
Equivalent amount of placebo powder |
|
| Mobile |
| Alabama |
| 36688 |
| United States |
| Braintree Research Site 28 | Phoenix | Arizona | 85018 | United States |
| Braintree Research Site 4 | Little Rock | Arkansas | 72211 | United States |
| Braintree Research Site 11 | Anaheim | California | 92801 | United States |
| Braintree Research Site 29 | Corona | California | 92879 | United States |
| Braintree Research Site 35 | Garden Grove | California | 92840 | United States |
| Braintree Research Site 32 | La Mirada | California | 90638 | United States |
| Braintree Research Site 50 | Sacramento | California | 95821 | United States |
| Braintree Research Site 51 | Westminster | California | 92638 | United States |
| Braintree Research Site 36 | Denver | Colorado | 80246 | United States |
| Braintree Research Site 45 | Clearwater | Florida | 33756 | United States |
| Braintree Research Site 10 | Hialeah | Florida | 33012 | United States |
| Braintree Research Site 37 | Hialeah | Florida | 33012 | United States |
| Braintree Research Site 39 | Hialeah | Florida | 33012 | United States |
| Braintree Research Site 2 | Miami | Florida | 33015 | United States |
| Braintree Research Site 6 | Miami | Florida | 33142 | United States |
| Braintree Research Site 38 | Miami | Florida | 33144 | United States |
| Braintree Research Site 52 | Miami | Florida | 33173 | United States |
| Braintree Research Site 19 | Miami Lakes | Florida | 33016 | United States |
| Braintree Research Site 44 | Miami Springs | Florida | 33166 | United States |
| Braintree Research Site 13 | Orlando | Florida | 32801 | United States |
| Braintree Research Site 43 | Pembroke Pines | Florida | 33024 | United States |
| Braintree Research Site 25 | Tamarac | Florida | 33319 | United States |
| Braintree Research Site 3 | Tampa | Florida | 33607 | United States |
| Braintree Research Site 1 | West Palm Beach | Florida | 33409 | United States |
| Braintree Research Site 41 | Atlanta | Georgia | 30328 | United States |
| Braintree Research Site 20 | Marietta | Georgia | 30060 | United States |
| Braintree Research Site 27 | Snellville | Georgia | 30078 | United States |
| Braintree Research Site 46 | Meridian | Idaho | 83642 | United States |
| Braintree Research Site 15 | Chicago | Illinois | 60602 | United States |
| Braintree Research Site 7 | Bastrop | Louisiana | 71220 | United States |
| Braintree Research Site 12 | New Orleans | Louisiana | 70124 | United States |
| Braintree Research Site 24 | Las Vegas | Nevada | 89102 | United States |
| Braintree Research Site 26 | Brooklyn | New York | 11230 | United States |
| Braintree Research Site 17 | Hartsdale | New York | 10530 | United States |
| Braintree Research Site 21 | High Point | North Carolina | 27262 | United States |
| Braintree Research Site 5 | Raleigh | North Carolina | 27612 | United States |
| Braintree Research Site 16 | Cincinnati | Ohio | 45215 | United States |
| Braintree Research Site 30 | Cleveland | Ohio | 44122 | United States |
| Braintree Research Site 48 | Columbus | Ohio | 43214 | United States |
| Braintree Research Site 9 | Dayton | Ohio | 45424 | United States |
| Braintree Research Site 18 | Smithfield | Pennsylvania | 15478 | United States |
| Braintree Research Site 23 | Lancaster | South Carolina | 29720 | United States |
| Braintree Research Site 22 | Chattanooga | Tennessee | 37421 | United States |
| Braintree Research Site 31 | Knoxville | Tennessee | 37938 | United States |
| Braintree Research Site 40 | Houston | Texas | 77081 | United States |
| Braintree Research Site 34 | San Antonio | Texas | 78209 | United States |
| Braintree Research Site 42 | West Jordan | Utah | 84088 | United States |
| Braintree Research Site 14 | Newport News | Virginia | 23606 | United States |
| Braintree Research Site 49 | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI400 Laxative | BLI400 Laxative (21 gm BLI400 powder) |
| BG001 | Placebo | BLI400 placebo (equivalent amount of placebo powder) |
| 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 | Treatment Response | The primary endpoint is the proportion 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. | modified ITT population - excludes subjects with significant protocol violations | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
6 months
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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) | 0 | 299 | 3 | 299 | 42 | 299 |
| EG001 | Placebo | BLI400 placebo (equivalent amount of placebo powder) | 0 | 304 | 8 | 304 | 33 | 304 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 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 | |
|---|---|---|---|---|
| VP, Clinical Affairs | Braintree Laboratories, Inc. | 781-843-2202 | john.mcgowan@sebelapharma.com |
| Jun 9, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|