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The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI800 approved preparation regimen | Experimental | BLI800 approved preparation regimen |
|
| BLI800 investigational preparation regimen | Experimental | BLI800 investigational preparation regimen |
|
| PEG-3350 based bowel preparation | Active Comparator | PEG-3350 based bowel preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-3350 based bowel preparation | Drug | solution for oral administration prior to colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken). | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36693 | United States | ||
| Advanced Clinical Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | BLI800 Approved Preparation Regimen | BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy |
| FG001 | BLI800 Investigational Preparation Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BLI800 approved preparation regimen | Drug | solution for oral administration prior to colonoscopy |
|
| BLI800 investigational preparation regimen | Drug | solution for oral administration prior to colonoscopy |
|
| Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days). | 7 days |
| Anaheim |
| California |
| 92801 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Delta Research Partners | Monroe | Louisiana | 71201 | United States |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | United States |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | United States |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | United States |
| Carolina Digestive Health Associates | Charlotte | North Carolina | 28262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Northwest Gastroenterology | Portland | Oregon | 97210 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Franklin Gastroenterology | Franklin | Tennessee | 37067 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
BLI800 investigational preparation regimen
BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy
| FG002 | PEG-3350 Based Bowel Preparation | PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BLI800 Approved Preparation Regimen | BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy |
| BG001 | BLI800 Investigational Preparation Regimen | BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy |
| BG002 | PEG-3350 Based Bowel Preparation | PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Percentage 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 Primary Efficacy Outcome includes all patients that took a portion of study preparation, except those that did not undergo colonoscopy for a reason other than safety or efficacy (e.g., patient could not get a ride to their colonoscopy). | Posted | Count of Participants | Participants | Day of colonoscopy |
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| Secondary | Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy | Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken). | All subjects that took any portion of study preparation. | Posted | Count of Participants | Participants | 2 days |
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| Secondary | Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7 | Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days). | All subjects who took a portion of study preparation. | Posted | Count of Participants | Participants | 7 days |
|
6 months
The Serious Adverse Event and All-Cause Mortality tables reflect all SAEs and deaths which occurred during the study. The Other Adverse Events table reflect all adverse events that occurred during the study.
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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 Approved Preparation Regimen | BLI800 approved preparation regimen BLI800 approved preparation regimen: solution for oral administration prior to colonoscopy | 0 | 184 | 4 | 184 | 145 | 184 |
| EG001 | BLI800 Investigational Preparation Regimen | BLI800 investigational preparation regimen BLI800 investigational preparation regimen: solution for oral administration prior to colonoscopy | 1 | 180 | 12 | 180 | 129 | 180 |
| EG002 | PEG-3350 Based Bowel Preparation | PEG-3350 based bowel preparation PEG-3350 based bowel preparation: solution for oral administration prior to colonoscopy | 0 | 177 | 3 | 177 | 127 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of vague upper abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Splenic injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bilateral silicone breast implant rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Lower anterior resection of the rectum | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Acute renal failure (post-operative) | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bilateral breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Bilateral mastectomy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Left breast tissue expander removal | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Sigmoid colon resection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Laparoscopic assisted anterior rectosigmoid colon resection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Septic shock secondary to cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Coffee ground emesis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Melena | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cirrhosis - Liver transplant | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Surgery for sigmoid colectomy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Colon resection | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Attenuated familial adenomatous polyposis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Stage II breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Worsening of re-current diabetic left ankle ulceration | Endocrine disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hospitalization from severe anemia due to vaginal bleed | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Hospitalization for chest pain | General disorders | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Urinary tract 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, GI | 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 |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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