Bowel Preparation
Conditions
Keywords
Bowel Preparation, Colonoscopy
Brief summary
Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.
Interventions
DRUGPicoPrep
PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.
DRUGHalfLytely
HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.
DRUGbisacodyl
Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy * Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period * Females of childbearing potential must undergo a pregnancy test at screening and again at randomization * Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy * Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions * Written informed consent obtained prior to study
Exclusion criteria
* Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.) * Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD) * Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures * Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome) * Ascites * Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus) * Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass) * Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension * Renal insufficiency (serum creatinine and potassium must be within normal limits) * Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days) * Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation * Hypersensitivity to active ingredients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist | Day 2 | Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as \>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as \>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Day 2 | Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary. |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
| Participants With Treatment-Emergent Adverse Events (TEAEs) | up to one month | Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication. |
| Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Day 2 | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Day 2 | Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PicoPrep Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy | 296 |
| HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. | 302 |
| Total | 598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Could not tolerate prep | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Power outage; colonoscopy not done | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Subject forgot | 0 | 1 |
| Overall Study | Unable to return for follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | PicoPrep | HalfLytely | Total |
|---|---|---|---|
| Age Continuous | 56.8 years STANDARD_DEVIATION 9.66 | 56.2 years STANDARD_DEVIATION 10.11 | 56.5 years STANDARD_DEVIATION 9.89 |
| Body Mass Index | 29.185 kg/m^2 STANDARD_DEVIATION 5.3209 | 29.541 kg/m^2 STANDARD_DEVIATION 6.1688 | 29.365 kg/m^2 STANDARD_DEVIATION 5.7634 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 15 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 288 Participants | 287 Participants | 575 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 22 participants | 32 participants | 54 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 274 participants | 268 participants | 542 participants |
| Sex: Female, Male Female | 192 Participants | 189 Participants | 381 Participants |
| Sex: Female, Male Male | 104 Participants | 113 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 167 / 296 | 194 / 302 |
| serious Total, serious adverse events | 2 / 296 | 1 / 302 |
Outcome results
Primary
Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as \>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as \>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PicoPrep | Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist | 83.0 percentage of participants |
| HalfLytely | Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist | 79.7 percentage of participants |
Secondary
Participants With Treatment-Emergent Adverse Events (TEAEs)
Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.
Time frame: up to one month
Population: Safety population of participants who were treated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 218 participants |
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AE | 2 participants |
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 0 participants |
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe TEAEs | 5 participants |
| PicoPrep | Participants With Treatment-Emergent Adverse Events (TEAEs) | Related TEAEs | 33 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | Severe TEAEs | 6 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | Any TEAE | 241 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs leading to discontinuation of study drug | 1 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | Deaths | 0 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | Related TEAEs | 29 participants |
| HalfLytely | Participants With Treatment-Emergent Adverse Events (TEAEs) | Serious AE | 1 participants |
Secondary
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PicoPrep | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | 81.3 percentage of participants |
| HalfLytely | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | 84.0 percentage of participants |
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Easy | 29.0 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Difficult | 1.0 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Tolerable | 11.6 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Very difficult | 0 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Very easy | 58.4 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Very difficult | 5.7 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Very easy | 16.1 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Easy | 21.1 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Tolerable | 45.3 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? | Difficult | 11.7 percentage of participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Good | 43.8 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Poor | 0.7 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Fair | 9.2 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Bad | 0.7 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Excellent | 45.5 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Bad | 3.4 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Excellent | 19.1 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Good | 48.7 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Fair | 25.5 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation | Poor | 3.4 percentage of participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Good | 48.1 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Poor | 1.7 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Tolerable | 23.9 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Bad | 0.7 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Excellent | 25.6 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Bad | 7.7 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Excellent | 4.0 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Good | 23.8 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Tolerable | 52.3 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was | Poor | 12.1 percentage of participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? | Yes | 99.7 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? | No | 0.3 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? | Yes | 92.3 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? | No | 7.7 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? | Yes | 93.2 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? | No | 6.8 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? | Yes | 59.4 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? | No | 40.6 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? | Yes | 4.8 percentage of participants |
| PicoPrep | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? | No | 95.2 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? | No | 85.6 percentage of participants |
| HalfLytely | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? | Yes | 14.4 percentage of participants |
p-value: <0.0001Fisher Exact
Other Pre-specified
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.
Time frame: Day 2
Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PicoPrep | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Mid-colon | 93.2 percentage of participants |
| PicoPrep | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Recto-sigmoid colon | 92.2 percentage of participants |
| PicoPrep | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Overall: ascending, mid, and recto-sigmoid colon | 78.9 percentage of participants |
| HalfLytely | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Mid-colon | 88.7 percentage of participants |
| HalfLytely | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Recto-sigmoid colon | 89.0 percentage of participants |
| HalfLytely | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist | Overall: ascending, mid, and recto-sigmoid colon | 78.0 percentage of participants |
Comparison: Mid colon comparison
Comparison: Recto-sigmoid colon comparison
Comparison: Overall comparison: ascending colon, mid colon and recto-sigmoid colon