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The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.
The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI800 | Experimental | BLI800 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI800 | Drug | BLI800 Bowel Preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Preparation Consumption | Question: How easy or difficult was it to consume the study preparation? | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Preparation Compliance | Question: Were you able to consume the entire preparation as instructed? | 2 days |
| Rating of Overall Experience | 2 days |
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Primary Inclusion Criteria:
Primary 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 | Great Neck | New York | 11023 | United States | ||
| Braintree Research Site 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI800 | BLI800 BLI800: BLI800 Bowel Preparation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI800 | BLI800 BLI800: BLI800 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 | Ease of Preparation Consumption | Question: How easy or difficult was it to consume the study preparation? | Posted | Count of Participants | Participants | 2 days |
|
|
2 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 | BLI800 | BLI800 (SUPREP Bowel Prep Kit) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal 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 | Aug 1, 2019 | Sep 25, 2023 | Prot_SAP_000.pdf |
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| Comparison to Prior Preparation | How did this preparation experience compare to your prior experience? | 2 days |
| Willingness to Repeat Preparation | Would you ask your doctor for this preparation again if you need another colonoscopy in the future? | 2 days |
| Refuse if Prescribed Again | Would you refuse the same preparation again if it were to be prescribed to you in the future? | 2 days |
| Rating of Aftertaste | 2 days |
| Bellevue |
| Washington |
| 98004 |
| 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 |
|
|
| Secondary | Preparation Compliance | Question: Were you able to consume the entire preparation as instructed? | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Secondary | Rating of Overall Experience | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Secondary | Comparison to Prior Preparation | How did this preparation experience compare to your prior experience? | Includes only those patients with a prior colonoscopy | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Secondary | Willingness to Repeat Preparation | Would you ask your doctor for this preparation again if you need another colonoscopy in the future? | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Secondary | Refuse if Prescribed Again | Would you refuse the same preparation again if it were to be prescribed to you in the future? | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Secondary | Rating of Aftertaste | Posted | Count of Participants | Participants | 2 days |
|
|
|
| 38 |
| 0 |
| 38 |
| 5 |
| 38 |
| Nausea | Gastrointestinal 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.