A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03017235
• Collaborator: (none)
• Enrollment: 917
• Locations: 14
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site: 65.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution; Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 917 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
• Actual Study Start Date: Feb 20, 2017
• Actual Primary Completion Date: Sep 15, 2017
• Actual Study Completion Date: Oct 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NaP/MC Oral Solution Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution	Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution; Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
Active Comparator: PREPOPIK®	Drug: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder; Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.; Other Names: PREPOPIK® PicoPrep®

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good" [During colonoscopy procedure (5-9 hours after completed treatment)]

   The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.

Secondary Outcome Measures

1. Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]

   The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.

2. Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]

   The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.

3. Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon [During colonoscopy procedure (5-9 hours after completed treatment)]

   The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.

4. Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

5. Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

6. Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

7. Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

8. Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.

9. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?) [During colonoscopy procedure (5-9 hours after completed treatment)]

   Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

10. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

11. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

12. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

13. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

14. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

15. Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

16. Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

17. Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

18. Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations) [During colonoscopy procedure (5-9 hours after completed treatment)]

    Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.

19. Percentage of Treatment-emergent Adverse Events(AEs) [From baseline (screening) up to day 28 after colonoscopy]

    Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.

20. Clinically Significant Changes in Vital Signs [From baseline (screening) up to day 28 after colonoscopy]

    Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position

21. Clinically Significant Changes in Electrocardiogram (ECG) [At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy]

    Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.

22. Clinically Significant Changes in Laboratory Values [At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy]

    Rated by the investigator based on out of range laboratory values

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 non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy

• Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.

• An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy

Exclusion Criteria:

• Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention

• Acute intestinal or gastric ulceration

• Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon

• Undergoing colonoscopy for foreign body removal or decompression

• Reduced level of consciousness or inability to swallow without aspiration

• Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures

• Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)

• Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites

• Severely reduced renal function (<30 mL/min/1.73 m2)

• Pregnant or lactating women

• Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1

• Rhabdomyolysis

• Chronic nausea and vomiting

• Hypermagnesemia

• Undergoing treatment with Lithium

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Associates	Huntsville	Alabama	United States	35801
2	Associated Gastroenterology Medical Group	Anaheim	California	United States	92801
3	GW Research, Inc.	Chula Vista	California	United States	91910
4	Precision Research Institute	San Diego	California	United States	92114
5	Connecticut Clinical Research Foundation	Bristol	Connecticut	United States	06010
6	Florida Clinical Research Group	Clearwater	Florida	United States	33759
7	Nature Coast Clinical Research	Inverness	Florida	United States	34452
8	Long Island Gastrointestinal Research Group LLC	Great Neck	New York	United States	11023
9	Kinston Medical Specialists, PA	Kinston	North Carolina	United States	28501
10	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
11	Hillmont GI	Flourtown	Pennsylvania	United States	19031
12	Advanced Research Institute	Ogden	Utah	United States	84405
13	Hotel Dieu Hospital	Kingston		Canada	K7L 5G2
14	Canadian Phase Onward, Inc.	Toronto		Canada	M3J 2C5

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Jan 25, 2017
• Statistical Analysis Plan - Dec 1, 2017

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03017235
• Other Study ID Numbers: 000253
• First Posted: Jan 11, 2017
• Last Update Posted: Nov 14, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Picosulfate sodium; Magnesium Oxide; Sodium Citrate; Citric Acid

Study Results

Participant Flow

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration. Split dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Split dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes. Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.
Period Title: Overall Study
STARTED	456	461
COMPLETED	444	447
NOT COMPLETED	12	14

Baseline Characteristics

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®	Total
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.	Total of all reporting groups
Overall Participants	448	453	901
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.2 (11.04)	57.1 (10.85)	57.2 (10.94)
Sex: Female, Male (Count of Participants)
Female	252 56.3%	250 55.2%	502 55.7%
Male	196 43.8%	203 44.8%	399 44.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	68 15.2%	71 15.7%	139 15.4%
Not Hispanic or Latino	380 84.8%	381 84.1%	761 84.5%
Unknown or Not Reported	0 0%	1 0.2%	1 0.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.2%	1 0.1%
Asian	13 2.9%	5 1.1%	18 2%
Native Hawaiian or Other Pacific Islander	1 0.2%	1 0.2%	2 0.2%
Black or African American	49 10.9%	41 9.1%	90 10%
White	376 83.9%	394 87%	770 85.5%
More than one race	2 0.4%	2 0.4%	4 0.4%
Unknown or Not Reported	7 1.6%	9 2%	16 1.8%
Child-bearing potential (Number) [Number]
Child bearing potential	252 56.3%	250 55.2%	502 55.7%
Yes	49 10.9%	47 10.4%	96 10.7%
No	203 45.3%	203 44.8%	406 45.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
Description	The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Number (95% Confidence Interval) [Percentage of participants]	87.7 19.6%	81.5 18%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NaP/MC Oral Solution, PREPOPIK®
	Comments	Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)
	Type of Statistical Test	Non-Inferiority
	Comments	The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.
Statistical Test of Hypothesis	p-Value	0.0067
	Comments	The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.
	Method	Weighted Percentage Difference
	Comments	CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; 1.8 to 10.9
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Lower limit of 95% CI > 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.

2. Secondary Outcome

Title	Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
Description	The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Number (95% Confidence Interval) [Percentage of subjects]	94.2	89.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NaP/MC Oral Solution, PREPOPIK®
	Comments	Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)
	Type of Statistical Test	Non-Inferiority
	Comments	If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.
Statistical Test of Hypothesis	p-Value	0.0099
	Comments	The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.
	Method	Weighted Percentage Difference
	Comments	CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	4.6
	Confidence Interval	(2-Sided) 95%; 1.1 to 8.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
Description	The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Number (95% Confidence Interval) [Percentage of subjects]	96.0	94.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NaP/MC Oral Solution, PREPOPIK®
	Comments	Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)
	Type of Statistical Test	Non-Inferiority
	Comments	If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.
Statistical Test of Hypothesis	p-Value	0.1781
	Comments	The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.
	Method	Weighted Percentage Difference
	Comments	CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.9 to 4.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
Description	The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Number (95% Confidence Interval) [Percentage of subjects]	94.6	91.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NaP/MC Oral Solution, PREPOPIK®
	Comments	Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)
	Type of Statistical Test	Non-Inferiority
	Comments	If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.
Statistical Test of Hypothesis	p-Value	0.0391
	Comments	The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.
	Method	Weighted Percentage Difference
	Comments	CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95%; 0.2 to 6.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
≤3/week	63 14.1%	47 10.4%
4 to 8/week	264 58.9%	299 66%
≥9/week	120 26.8%	105 23.2%
Response not provided	0 0%	1 0.2%
Not applicable	1 0.2%	1 0.2%

6. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
<25%	443 98.9%	448 98.9%
25% - 50%	1 0.2%	1 0.2%
50% - 75%	0 0%	2 0.4%
≥75%	1 0.2%	0 0%
Response not provided	2 0.4%	1 0.2%
Not applicable	1 0.2%	1 0.2%

7. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Easy to acceptable	400 89.3%	433 95.6%
Somewhat difficult	41 9.2%	17 3.8%
Very difficult	4 0.9%	1 0.2%
Unacceptable	2 0.4%	1 0.2%
Not applicable	1 0.2%	1 0.2%

8. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not willing at all	11 2.5%	6 1.3%
Somewhat willing	75 16.7%	38 8.4%
Mostly willing	361 80.6%	408 90.1%
Not applicable	1 0.2%	1 0.2%

9. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Yes	11 2.5%	8 1.8%
No	104 23.2%	93 20.5%
No difficulties	310 69.2%	320 70.6%
No health issues	84 18.8%	109 24.1%
Response not provided	0 0%	3 0.7%

10. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	371 82.8%	426 94%
Moderately bothered	63 14.1%	22 4.9%
Severely bothered	11 2.5%	2 0.4%
No response	1 0.2%	3 0.7%
Not applicable	2 0.4%	0 0%

11. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	382 85.3%	387 85.4%
Moderately bothered	53 11.8%	57 12.6%
Severely bothered	10 2.2%	6 1.3%
No response	2 0.4%	3 0.7%
Not applicable	1 0.2%	0 0%

12. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	335 74.8%	328 72.4%
Moderately bothered	86 19.2%	85 18.8%
Severely bothered	25 5.6%	37 8.2%
No response	1 0.2%	3 0.7%
Not applicable	1 0.2%	0 0%

13. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	416 92.9%	435 96%
Moderately bothered	23 5.1%	11 2.4%
Severely bothered	6 1.3%	2 0.4%
No response	2 0.4%	4 0.9%
Not applicable	1 0.2%	0 0%

14. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	403 90%	402 88.7%
Moderately bothered	35 7.8%	40 8.8%
Severely bothered	7 1.6%	6 1.3%
No response	2 0.4%	4 0.9%
Not applicable	1 0.2%	1 0.2%

15. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	427 95.3%	432 95.4%
Moderately bothered	15 3.3%	15 3.3%
Severely bothered	3 0.7%	3 0.7%
No response	1 0.2%	2 0.4%
Not applicable	2 0.4%	1 0.2%

16. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Not bothered-Mildly bothered	396 88.4%	396 87.4%
Moderately bothered	38 8.5%	47 10.4%
Severely bothered	13 2.9%	7 1.5%
No response	0 0%	2 0.4%
Not applicable	1 0.2%	1 0.2%

17. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
No	261 58.3%	281 62%
Yes	185 41.3%	171 37.7%
Response not provided	1 0.2%	2 0.4%
Not applicable	1 0.2%	0 0%

18. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
GoLytely	56 12.5%	52 11.5%
Moviprep	14 3.1%	17 3.8%
MiraLax	20 4.5%	20 4.4%
Other	34 7.6%	39 8.6%
Do not remember	137 30.6%	53 11.7%

19. Secondary Outcome

Title	Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Description	Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time Frame	During colonoscopy procedure (5-9 hours after completed treatment)

Outcome Measure Data

Analysis Population Description

The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Worse than before	5 1.1%	5 1.1%
About the same as before	62 13.8%	67 14.8%
Better than before	190 42.4%	209 46.1%
Response not provided	4 0.9%	0 0%

20. Secondary Outcome

Title	Percentage of Treatment-emergent Adverse Events(AEs)
Description	Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
Time Frame	From baseline (screening) up to day 28 after colonoscopy

Outcome Measure Data

Analysis Population Description

The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Number [Percentage of adverse events]	84.4	84.8

21. Secondary Outcome

Title	Clinically Significant Changes in Vital Signs
Description	Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
Time Frame	From baseline (screening) up to day 28 after colonoscopy

Outcome Measure Data

Analysis Population Description

The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Hypertension	0 0%	4 0.9%
Orthostatic hypotension	1 0.2%	2 0.4%
Blood pressure increased	2 0.4%	0 0%
Hypotension	1 0.2%	1 0.2%

22. Secondary Outcome

Title	Clinically Significant Changes in Electrocardiogram (ECG)
Description	Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
Time Frame	At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy

Outcome Measure Data

Analysis Population Description

The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Bradycardia	3 0.7%	0 0%
Bundle branch block left	0 0%	2 0.4%
Extrasystoles	0 0%	2 0.4%
Ventricular extrasystoles	2 0.4%	0 0%
Atrial fibrillation	1 0.2%	0 0%
Bundle branch block right	1 0.2%	0 0%
Palpitations	1 0.2%	0 0%
Sinus bradycardia	0 0%	1 0.2%
Tachycardia	0 0%	1 0.2%
Cardiac murmur	1 0.2%	0 0%

23. Secondary Outcome

Title	Clinically Significant Changes in Laboratory Values
Description	Rated by the investigator based on out of range laboratory values
Time Frame	At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy

Outcome Measure Data

Analysis Population Description

The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.

Arm/Group Title	NaP/MC Oral Solution	PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Measure Participants	448	453
Hematology: Anaemia	1 0.2%	1 0.2%
Hematology: Leukopenia	1 0.2%	0 0%
Hematology: Lymphocytosis	0 0%	1 0.2%
Hematology: Neutropenia	1 0.2%	0 0%
Hematology: Normocytic anaemia	1 0.2%	0 0%
Hemotology: Platelet count decreased	0 0%	1 0.2%
Clinical Chemistry: Hypermagnesaemia	9 2%	23 5.1%
Clinical chemistry:Blood bicarbonate decreased	6 1.3%	3 0.7%
Clinical chemistry: Hypokalemia	4 0.9%	0 0%
Clinical chemistry: Hyperglycaemia	2 0.4%	1 0.2%
Clinical chemistry: Hypoglycaemia	3 0.7%	0 0%
Clinical chemistry: Hyperkalaemia	0 0%	2 0.4%
Clinical chemistry: Hypomagnasaemia	2 0.4%	0 0%
Clinical chemistry: Blood creatinine increased	0 0%	1 0.2%
Clinical chemistry: Blood potassium decreased	1 0.2%	0 0%
Clinical chemistry: Hypochloraemia	0 0%	1 0.2%
Clinical chemistry: Hyperbilirubinaemia	0 0%	1 0.2%
Urinalysis	0 0%	0 0%

Adverse Events

Time Frame	From baseline (screening) upto 28 days after colonoscopy.
Arm/Group Title	NaP/MC Oral Solution		PREPOPIK®
Arm/Group Description	Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution Supplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration.		Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
All Cause Mortality
	NaP/MC Oral Solution		PREPOPIK®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/448 (0%)		0/453 (0%)
Serious Adverse Events
	NaP/MC Oral Solution		PREPOPIK®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/448 (2%)		6/453 (1.3%)
Cardiac disorders
Atrial fibrillation	1/448 (0.2%)	1	0/453 (0%)	0
Gastrointestinal disorders
Ascites	1/448 (0.2%)	1	0/453 (0%)	0
Gastrointestinal haemorrhage	0/448 (0%)	0	1/453 (0.2%)	1
Infections and infestations
Influenza	0/448 (0%)	0	1/453 (0.2%)	1
Injury, poisoning and procedural complications
Post procedural haemorrhage	1/448 (0.2%)	1	0/453 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	4/448 (0.9%)	4	0/453 (0%)	0
Rectal adenocarcinoma	2/448 (0.4%)	2	1/453 (0.2%)	1
Basal cell carcinoma	0/448 (0%)	0	1/453 (0.2%)	1
Breast cancer metastatic	1/448 (0.2%)	1	0/453 (0%)	0
Carcinoid tumour of the gastrointestinal tract	0/448 (0%)	0	1/453 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	0/448 (0%)	0	1/453 (0.2%)	1
Other (Not Including Serious) Adverse Events
	NaP/MC Oral Solution		PREPOPIK®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	378/448 (84.4%)		384/453 (84.8%)
Gastrointestinal disorders
Haemorrhoids	150/448 (33.5%)	162	155/453 (34.2%)	167
Large intestine polyp	93/448 (20.8%)	157	105/453 (23.2%)	181
Diverticulum intestinal	70/448 (15.6%)	75	70/453 (15.5%)	73
Diverticulum	64/448 (14.3%)	64	59/453 (13%)	59
Infections and infestations
Investigations	25/448 (5.6%)	26	23/453 (5.1%)	26
Infections and infestations	27/448 (6%)	29	35/453 (7.7%)	35
Metabolism and nutrition disorders
Hypermagnesaemia	9/448 (2%)	9	23/453 (5.1%)	26
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma	133/448 (29.7%)	237	128/453 (28.3%)	211
Nervous system disorders
Nervous system disorders	27/448 (6%)	27	30/453 (6.6%)	34

Limitations/Caveats

[Not Specified]

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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.