Colon Cleansing
Conditions
Keywords
Colon Cleansing, Bowel Prep, Colonoscopy
Brief summary
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
Interventions
DRUGPolyethylene glycol
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
DRUGOral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 70 years of age, inclusive * Scheduled for colonoscopy within 21 days of the screening visit * Able to swallow tablets the size of a multivitamin without difficulty
Exclusion criteria
* History of biopsy-proven acute phosphate nephropathy * Known allergy or hypersensitivity to treatment arms * History of gastric stapling or bypass procedure or history of gastric retention * History of any other sodium phosphate preparation within 6 months prior to colonoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OsmoPrep Tablets Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L | 1,041 |
| HalfLytely and Bisacodyl Tablet Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L | 1,051 |
| Total | 2,092 |
Baseline characteristics
| Characteristic | OsmoPrep Tablets | HalfLytely and Bisacodyl Tablet | Total |
|---|---|---|---|
| Age, Customized <65 | 906 Participants | 932 Participants | 1838 Participants |
| Age, Customized >=65 | 135 Participants | 119 Participants | 254 Participants |
| Sex: Female, Male Female | 616 Participants | 645 Participants | 1261 Participants |
| Sex: Female, Male Male | 425 Participants | 406 Participants | 831 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 443 / 1,041 | 352 / 1,051 |
| serious Total, serious adverse events | 20 / 1,041 | 19 / 1,051 |
Outcome results
Primary
Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OsmoPrep Tablets | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Excellent | 618 Participants |
| OsmoPrep Tablets | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Good | 275 Participants |
| OsmoPrep Tablets | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Fair | 116 Participants |
| OsmoPrep Tablets | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Inadequate | 23 Participants |
| HalfLytely and Bisacodyl Tablet | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Inadequate | 88 Participants |
| HalfLytely and Bisacodyl Tablet | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Excellent | 243 Participants |
| HalfLytely and Bisacodyl Tablet | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Fair | 286 Participants |
| HalfLytely and Bisacodyl Tablet | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | Good | 423 Participants |