Colonoscopy
Conditions
Keywords
colonoscopy, bowel preparation
Brief summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
Interventions
DRUGPEG electrolyte lavage solution + bisacodyl - reformulation
multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
DRUGPEG electrolyte lavage solution + bisacodyl
multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications: 2. At least 18 years of age 3. Otherwise in good health, as determined by physical exam and medical history 4. If female, and of child-bearing potential, is using an acceptable form of birth control 5. Negative urine pregnancy test at screening, if applicable 6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion criteria
1. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon 2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration 3. Subjects who are undergoing colonoscopy for foreign body removal and decompression 4. Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics 5. Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics 6. Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia 7. Subjects who are pregnant or lactating, or intending to become pregnant during the study 8. Subjects of childbearing potential who refuse a pregnancy test 9. Subjects who are allergic to any preparation components 10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures 11. Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | during colonoscopy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HalfLytely With 5mg Bisacodyl Investigational dose | 154 |
| HalfLytely With 10mg Bisacodyl Active Control | 154 |
| Total | 308 |
Baseline characteristics
| Characteristic | HalfLytely With 10mg Bisacodyl | HalfLytely With 5mg Bisacodyl | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 44 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants | 110 Participants | 226 Participants |
| Age Continuous | 55.0 years STANDARD_DEVIATION 13 | 56.8 years STANDARD_DEVIATION 12.1 | 55.9 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 154 participants | 154 participants | 308 participants |
| Sex: Female, Male Female | 90 Participants | 78 Participants | 168 Participants |
| Sex: Female, Male Male | 64 Participants | 76 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 117 / 154 | 129 / 154 |
| serious Total, serious adverse events | 0 / 154 | 1 / 154 |
Outcome results
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.
Time frame: during colonoscopy
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HalfLytely With 5mg Bisacodyl | Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | 77.6 percent of participants |
| HalfLytely With 10mg Bisacodyl | Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | 80.1 percent of participants |
Comparison: The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%.p-value: 0.00595% CI: [-11.9, 6.8]Chi-squared