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To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HalfLytely with 10mg bisacodyl | Active Comparator | Active control |
|
| HalfLytely with 5mg bisacodyl | Experimental | Investigational dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG electrolyte lavage solution + bisacodyl - reformulation | Drug | multi dose formulation (tablet/solution) for oral administration prior to colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure". | during colonoscopy |
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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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Advanced Clinical Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | HalfLytely With 5mg Bisacodyl | Investigational dose |
| FG001 | HalfLytely With 10mg Bisacodyl | Active Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PEG electrolyte lavage solution + bisacodyl | Drug | multi dose preparation (tablet/solution) for oral administration prior to colonoscopy |
|
| Orange |
| California |
| 92869 |
| United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| United Medical Research | New Smyrna Beach | Florida | 32168 | United States |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | United States |
| Franklin Gastroenterology | Franklin | Tennessee | 37067 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HalfLytely With 5mg Bisacodyl | Investigational dose |
| BG001 | HalfLytely With 10mg Bisacodyl | Active Control |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = "excellent" (no more than small bits of adherent feces/fluid); 3 = "good" (small amounts of feces or fluid not interfering with the exam); 2 = "fair" (enough feces or fluid to prevent a completely reliable exam); 1 = "poor" (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a "success" and grades of 2 or 1 were considered a "failure". | The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy. | Posted | Number | 95% Confidence Interval | percent of participants | during colonoscopy |
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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 | HalfLytely With 5mg Bisacodyl | Investigational dose | 0 | 154 | 117 | 154 | ||
| EG001 | HalfLytely With 10mg Bisacodyl | Active Control | 1 | 154 | 129 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overall Discomfort | General disorders | MedDRA (Unspecified) | Systematic Assessment | Patient completed questionnaire - expected preparation symptoms were rated as "None", "Mild", "Bothersome", "Distressing" or "Severely Distressing" |
|
| Abdominal fullness | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Patient completed questionnaire - expected preparation symptoms were rated as "None", "Mild", "Bothersome", "Distressing" or "Severely Distressing" |
|
| Abdominal cramping | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Patient completed questionnaire - expected preparation symptoms were rated as "None", "Mild", "Bothersome", "Distressing" or "Severely Distressing" |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Patient completed questionnaire - expected preparation symptoms were rated as "None", "Mild", "Bothersome", "Distressing" or "Severely Distressing" |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Total number of patients experiencing a non-serious adverse event is based on all adverse events, not just those events above the reporting threshold of 3%
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John McGowan, Associate Director, Clinical Research | Braintree Laboratories, Inc. | 781-843-2202 | jmcgowan@braintreelabs.com |
| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
|