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To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycol 3350 based bowel preparation | Active Comparator | Polyethylene glycol 3350 based bowel preparation |
|
| BLI800 | Experimental | BLI800 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI800 | Drug | Solution for oral administration prior to colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Residual Stool - Cecum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Stool - Ascending Colon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McGowan, MPH | Braintree Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Jupiter Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20646695 | Derived | Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyethylene Glycol 3350 Based Bowel Preparation | Active control - oral solution, 1 administration |
| FG001 | BLI800 | Investigational prep - oral solution, 1 administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polyethylene Glycol 3350 Based Bowel Preparation | Active control - oral solution, 1 administration |
| BG001 | BLI800 | Investigational prep - oral solution, 1 administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations. | Posted | Number | percentage of participants | 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 | Polyethylene Glycol 3350 Based Bowel Preparation | Active control - oral solution, 1 administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
As prespecified in the study protocol, expected prep related side effects (nausea, vomiting, cramping, bloating and overall discomfort) were only documented as AEs if patients rated them severely distressing on the study questionnaire.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John McGowan | Braintree Laboratories, Inc. | 781-843-2202 | jmcgowan@braintreelabs.com |
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| Polyethylene glycol 3350 based bowel preparation |
| Drug |
Solution for oral administration prior to colonoscopy |
|
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
| 2 days |
| Assessment of Residual Stool - Transverse Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Stool - Descending Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Stool - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Fluid - Cecum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Fluid - Ascending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Fluid - Transverse Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Fluid - Descending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Assessment of Residual Fluid - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days |
| Subject Symptom Scores | Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing). | 2 days |
| Mean Change in Serum Chemistry (mg/dL) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | up to 15 days |
| Mean Change in Serum Chemistry (mEq/L) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | up to 15 days |
| Jupiter |
| Florida |
| 33458 |
| United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Long Island GI Research Group | Great Neck | New York | 11023 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Assessment of Residual Stool - Cecum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Stool - Ascending Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Stool - Transverse Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Stool - Descending Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Stool - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Fluid - Cecum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Fluid - Ascending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Fluid - Transverse Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Fluid - Descending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Assessment of Residual Fluid - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | Posted | Number | percentage of participants | 2 days |
|
|
|
|
| Secondary | Subject Symptom Scores | Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing). | Posted | Mean | Standard Deviation | units on a scale | 2 days |
|
|
|
| Secondary | Mean Change in Serum Chemistry (mg/dL) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | Posted | Mean | Standard Deviation | mg/dL | up to 15 days |
|
|
|
| Secondary | Mean Change in Serum Chemistry (mEq/L) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | Posted | Mean | Standard Deviation | mEq/L | up to 15 days |
|
|
|
| 1 |
| 67 |
| 6 |
| 67 |
| EG001 | BLI800 | Investigational prep - oral solution, 1 administration | 0 | 63 | 1 | 63 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo.
| Moderate |
|
| Excess |
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| Moderate |
|
| Excess |
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| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Moderate |
|
| Excess |
|
| Nausea |
|
| Overall discomfort |
|
| Creatinine |
|
| Phosphorus |
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| Magnesium |
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| Potassium |
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| Sodium |
|