Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI4900 | Experimental | BLI4900 Bowel Preparation |
|
| PEG Control | Active Comparator | Polyethylene glycol-based bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI4900 | Drug | BLI4900 Bowel Preparation |
| |
| PEG Control |
| Measure | Description | Time Frame |
|---|---|---|
| % of Subjects With Successful Bowel Preparation | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) | Day of colonoscopy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Braintree Research Site 1 | Anaheim | California | 92801 | United States | ||
| Braintree Research Site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38082231 | Derived | Wiener G, Winkle P, McGowan JD, Cleveland MV, Di Palma JA. A Phase 2 evaluation of a new flavored peg and sulfate solution compared to an over-the-counter laxative, peg and sports drink bowel preparation combination. BMC Gastroenterol. 2023 Dec 11;23(1):433. doi: 10.1186/s12876-023-03069-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BLI4900-3 | Formulation 3 |
| FG001 | BLI4900-5 | Formulation 5 |
| FG002 | BLI4900-6 | Formulation 6 |
| FG003 | PEG-SD | Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BLI4900-3 | Formulation 3 |
| BG001 | BLI4900-5 | Formulation 5 |
| BG002 |
| 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 | % of Subjects With Successful Bowel Preparation | % of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent) | Posted | Count of Participants | Participants | Day of colonoscopy |
|
2 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BLI4900-3 | Formulation 3 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distension | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D, GI | Braintree Laboratories, Inc. | 7818432202 | studydirector@sebelapharma.com |
Not provided
| 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 | Jul 8, 2019 | Sep 29, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Polyethylene glycol-based bowel preparation |
|
| Chula Vista |
| California |
| 91910 |
| United States |
| Braintree Research Site 4 | San Diego | California | 92114 | United States |
| Braintree Clinical Research Site 2 | Ogden | Utah | 84405 | United States |
| BLI4900-6 |
Formulation 6 |
| BG003 | PEG-SD | Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl) |
| BG004 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
|
| OG003 |
| PEG-SD |
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl) |
|
|
| 21 |
| 0 |
| 21 |
| 13 |
| 21 |
| EG001 | BLI4900-5 | Formulation 5 | 0 | 40 | 0 | 40 | 31 | 40 |
| EG002 | BLI4900-6 | Formulation 6 | 0 | 41 | 0 | 41 | 13 | 41 |
| EG003 | PEG-SD | Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl) | 0 | 19 | 1 | 19 | 14 | 19 |
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| hypernatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| migraine | Nervous system disorders | Non-systematic Assessment |
|
| orthostatic hypotension | Vascular disorders | 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.