Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01073943
• Collaborator: (none)
• Enrollment: 603
• Locations: 11
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 54.8
• Patients Per Site Per Month: 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: PicoPrep; Drug: HalfLytely; Drug: bisacodyl	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 603 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of "Day Before" PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: PicoPrep; 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.; Other Names: PicoPrep™ Prepopik™
Active Comparator: 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.	Drug: HalfLytely; 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.; Drug: bisacodyl; Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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.

Other Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Clinical Research Group	Clearwater	Florida	United States
2	Investigational site	Hollywood	Florida	United States
3	Nature Coast Clinical Research	Inverness	Florida	United States
4	Gastroenterology Associates, LLC	Baton Rouge	Louisiana	United States
5	Louisiana Research Center	Shreveport	Louisiana	United States
6	Investigative Clinical Research	Annapolis	Maryland	United States
7	NJ Physicians, LLC	Passaic	New Jersey	United States
8	Vital re:Search, Inc	Greensboro	North Carolina	United States
9	Gastroenterology Research Consultants of Greater Cincinnati	Cincinnati	Ohio	United States
10	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States
11	Gastroenterology Associates	Kingsport	Tennessee	United States

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01073943
• Other Study ID Numbers: 2009-02
• First Posted: Feb 23, 2010
• Last Update Posted: Oct 30, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Ferring Pharmaceuticals: Bowel Preparation; Colonoscopy
• Additional relevant MeSH terms: Bisacodyl; Picosulfate sodium

Study Results

Participant Flow

Arm/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Period Title: Overall Study
STARTED	300	303
Safety Population (Treated)	296	302
Intent to Treat Population	294	300
COMPLETED	287	295
NOT COMPLETED	13	8

Baseline Characteristics

Arm/Group Title	PicoPrep	HalfLytely	Total
Arm/Group Description	"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	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.	Total of all reporting groups
Overall Participants	296	302	598
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (9.66)	56.2 (10.11)	56.5 (9.89)
Sex: Female, Male (Count of Participants)
Female	192 64.9%	189 62.6%	381 63.7%
Male	104 35.1%	113 37.4%	217 36.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 2.7%	15 5%	23 3.8%
Not Hispanic or Latino	288 97.3%	287 95%	575 96.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	0 0%	1 0.3%	1 0.2%
Asian	0 0%	1 0.3%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	22 7.4%	32 10.6%	54 9%
White	274 92.6%	268 88.7%	542 90.6%
Other	0 0%	0 0%	0 0%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.185 (5.3209)	29.541 (6.1688)	29.365 (5.7634)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Arm/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	294	300
Number [percentage of participants]	83.0 28%	79.7 26.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.3
	Confidence Interval	(1-Sided) 97.5%; -2.9 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Arm/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	294	300
Number [percentage of participants]	81.3 27.5%	84.0 27.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.7
	Confidence Interval	(1-Sided) 97.5%; -8.8 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	293	298
Very easy	58.4 19.7%	16.1 5.3%
Easy	29.0 9.8%	21.1 7%
Tolerable	11.6 3.9%	45.3 15%
Difficult	1.0 0.3%	11.7 3.9%
Very difficult	0 0%	5.7 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	293	298
Yes	99.7 33.7%	92.3 30.6%
No	0.3 0.1%	7.7 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	292	298
Excellent	45.5 15.4%	19.1 6.3%
Good	43.8 14.8%	48.7 16.1%
Fair	9.2 3.1%	25.5 8.4%
Poor	0.7 0.2%	3.4 1.1%
Bad	0.7 0.2%	3.4 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	293	298
Excellent	25.6 8.6%	4.0 1.3%
Good	48.1 16.3%	23.8 7.9%
Tolerable	23.9 8.1%	52.3 17.3%
Poor	1.7 0.6%	12.1 4%
Bad	0.7 0.2%	7.7 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	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?
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	293	298
Yes	93.2 31.5%	59.4 19.7%
No	6.8 2.3%	40.6 13.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

8. Secondary Outcome

Title	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?
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	293	298
Yes	4.8 1.6%	14.4 4.8%
No	95.2 32.2%	85.6 28.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

9. Secondary Outcome

Title	Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	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

Outcome Measure Data

Analysis Population Description

Safety population of participants who were treated.

Arm/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	296	302
Any TEAE	218 73.6%	241 79.8%
Deaths	0 0%	0 0%
Serious AE	2 0.7%	1 0.3%
TEAEs leading to discontinuation of study drug	0 0%	1 0.3%
Severe TEAEs	5 1.7%	6 2%
Related TEAEs	33 11.1%	29 9.6%

10. Other Pre-specified Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Arm/Group Title	PicoPrep	HalfLytely
Arm/Group Description	"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	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.
Measure Participants	294	300
Mid-colon	93.2 31.5%	88.7 29.4%
Recto-sigmoid colon	92.2 31.1%	89.0 29.5%
Overall: ascending, mid, and recto-sigmoid colon	78.9 26.7%	78.0 25.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments	Mid colon comparison
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.5
	Confidence Interval	(1-Sided) 97.5%; -0.1 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments	Recto-sigmoid colon comparison
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.2
	Confidence Interval	(1-Sided) 97.5%; -1.5 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PicoPrep, HalfLytely
	Comments	Overall comparison: ascending colon, mid colon and recto-sigmoid colon
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.9
	Confidence Interval	(1-Sided) 97.5%; -5.7 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Treatment-emergent AEs occurring from Day 1 up to one month.
Arm/Group Title	PicoPrep		HalfLytely
Arm/Group Description	"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		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.
All Cause Mortality
	PicoPrep		HalfLytely
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PicoPrep		HalfLytely
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/296 (0.7%)		1/302 (0.3%)
Cardiac disorders
Acute coronary syndrome	1/296 (0.3%)		0/302 (0%)
Gastrointestinal disorders
Ileus	0/296 (0%)		1/302 (0.3%)
Injury, poisoning and procedural complications
Anastomatic complication	1/296 (0.3%)		0/302 (0%)
Metabolism and nutrition disorders
Dehydration	1/296 (0.3%)		0/302 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/296 (0.3%)		0/302 (0%)
Other (Not Including Serious) Adverse Events
	PicoPrep		HalfLytely
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	167/296 (56.4%)		194/302 (64.2%)
Gastrointestinal disorders
Colonic polyp	37/296 (12.5%)		47/302 (15.6%)
Diverticulum	63/296 (21.3%)		85/302 (28.1%)
Diverticulum intestinal	27/296 (9.1%)		23/302 (7.6%)
Haemorrhoids	85/296 (28.7%)		81/302 (26.8%)
Nausea	11/296 (3.7%)		16/302 (5.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma	47/296 (15.9%)		57/302 (18.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.