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The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI4700 | Experimental | BLI4700 Bowel Preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI4700 | Drug | BLI4700 bowel preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With Successful Bowel Cleansing | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent) | Day of colonoscopy |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Braintree Research Site 1 | Anaheim | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI4700 (Study Formulation 1) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| FG001 | BLI4700 (Study Formulation 2) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| FG002 | BLI4700 (Study Formulation 3) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| FG003 | BLI4700 (Study Formulation 4) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI4700 (Study Formulation 1) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| BG001 | BLI4700 (Study Formulation 2) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number and Percentage of Subjects With Successful Bowel Cleansing | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent) | Efficacy population - all patients that took any portion of the preparation and did not discontinue from the study for a reason other than safety or efficacy. | Posted | Count of Participants | Participants | Day of colonoscopy |
|
7 days
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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 | BLI4700 (Study Formulation 1) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D, Gastroenterology | Braintree Laboratories, Inc. | 781-843-2202 | studydirector@sebelapharma.com |
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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 | Jun 15, 2017 | Sep 29, 2023 | Prot_SAP_000.pdf |
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| BG002 | BLI4700 (Study Formulation 3) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| BG003 | BLI4700 (Study Formulation 4) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | BLI4700 (Study Formulation 3) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
| OG003 | BLI4700 (Study Formulation 4) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 30 |
| 40 |
| EG001 | BLI4700 (Study Formulation 2) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation | 0 | 37 | 0 | 37 | 24 | 37 |
| EG002 | BLI4700 (Study Formulation 3) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation | 0 | 17 | 0 | 17 | 12 | 17 |
| EG003 | BLI4700 (Study Formulation 4) | BLI4700 Bowel Preparation BLI4700: BLI4700 tablet bowel preparation | 0 | 20 | 1 | 20 | 15 | 20 |
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Study subjects were queried by research staff for this expected preparation symptom. |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Study subjects were queried by research staff for this expected preparation symptom. |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | Study subjects were queried by research staff for this expected preparation symptom. |
|
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment | Study subjects were queried by research staff for this expected preparation symptom. |
|
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