Not provided
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 BLI4700 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 |
|---|---|---|---|
| BLI4700 | Experimental | BLI4700 Bowel Preparation (Investigational Regimen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI4700 | Drug | BLI4700 Bowel Preparation (Investigational Regimen) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Successful Bowel Preparation | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). | Day of colonoscopy |
Not provided
Not provided
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Not provided
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 2 |
Not provided
Not provided
Not provided
Not provided
Not provided
The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BLI4700 | BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BLI4700 | BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen) |
| 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 | Proportion of Subjects With Successful Bowel Preparation | Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor). | The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm. | Posted | Count of Participants | Participants | Day of colonoscopy |
|
|
2 days
The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
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 | BLI4700 | BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen) |
Not provided
| 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 | Feb 16, 2017 | Sep 29, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bastrop |
| Louisiana |
| 71220 |
| United States |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 14 |
| 17 |
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | 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.