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The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI800 - Dose 1 | Experimental | BLI800 oral solution |
|
| BLI800 - Dose 2 | Experimental | BLI800 oral solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI800 - Dose 1 | Drug | BLI800 oral solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa | 2 days |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | United States | |||
| Children's Center for Digestive Health Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI800 - Dose 1 | BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz) |
| FG001 | BLI800 - Dose 2 | BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| BLI800 - Dose 2 | Drug | BLI800 oral solution |
|
|
| Atlanta |
| Georgia |
| United States |
| Delta Research Partners | Bastrop | Louisiana | United States |
| Gastrointestinal Associates | Jackson | Mississippi | United States |
| University of Buffalo Pediatric Associates | Buffalo | New York | United States |
|
| COMPLETED |
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| NOT COMPLETED |
|
Safety population - all subjects that took preparation.
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI800 - Dose 1 | BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz) |
| BG001 | BLI800 - Dose 2 | BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Puburtal Staging | Pubertal Tanner Staging from I (prepubertal) to V (adult genitalia) | Count of Participants | Participants |
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| 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 Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent) | Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa | Efficacy population | Posted | Count of Participants | 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 | BLI800 - Dose 1 | BLI800 oral solution BLI800 - Dose 1: BLI800 oral solution (6 oz) | 0 | 16 | 0 | 16 | 13 | 16 |
| EG001 | BLI800 - Dose 2 | BLI800 oral solution BLI800 - Dose 2: BLI800 oral solution (4.5 oz) | 0 | 13 | 0 | 13 | 12 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | Non-systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anorectal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Eructation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
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| Injection site pain | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Bacterial test | Investigations | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | Non-systematic Assessment |
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| Protein urine present | Investigations | Non-systematic Assessment |
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| Urinary casts | Investigations | Non-systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Helicobacter infection | Infections and infestations | 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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D, Gastroenterology | Braintree Laboratories, Inc. | 781-843-2202 | studydirector@sebelapharma.com |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| II |
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| III |
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| IV |
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| V |
|