Investigation of PicoPrep Versus HalfLytely for Bowel Pre... | NCT01073943

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PicoPrep	Experimental	"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
HalfLytely	Active Comparator	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 Drug: bisacodyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PicoPrep	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist	Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.	Day 2

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist	Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist	Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Florida Clinical Research Group		Clearwater	Florida		United States
Investigational site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	HalfLytely

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000296 BG001302 BG002598

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.8± 9.66 BG00156.2± 10.11 BG00256.5± 9.89

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000192 BG001189 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0008 BG00115 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00029.185± 5.3209 BG00129.541± 6.1688 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.

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

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts
Participants	OG000294 OG001300

Title

Denominators

Categories

Title	Measurements
	OG00083.0 OG00179.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Net)	3.3			1-Sided	97.5	-2.9					Yes	Non-Inferiority or Equivalence	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%.

Secondary

Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.

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

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Secondary

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

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts

Secondary

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

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts
Participants

Secondary

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

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts

Secondary

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

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts

Secondary

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts

Secondary

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?

Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

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.

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Units	Counts

Secondary

Participants With Treatment-Emergent Adverse Events (TEAEs)

Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.

Safety population of participants who were treated.

Posted

Number

participants

up to one month

ID	Title	Description
OG000	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
OG001	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.

Other Pre-specified

Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.

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

Posted

Number

percentage of participants

Day 2

ID	Title	Description
OG000	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
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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			2	296	167	296
EG001	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.			1	302	194	302

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0001 affected296 at risk EG0010 affected302 at risk
Anastomatic complication	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 affected296 at risk EG0010 affected302 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected296 at risk EG0010 affected302 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected296 at risk EG0010 affected302 at risk
Ileus	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected296 at risk EG0011 affected302 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colonic polyp	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00037 affected296 at risk EG00147 affected302 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00063 affected296 at risk EG00185 affected302 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00027 affected296 at risk EG00123 affected302 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00085 affected296 at risk EG00181 affected302 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00011 affected296 at risk EG00116 affected302 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG00047 affected296 at risk EG00157 affected302 at risk

ID	Term
D003408	Cresols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals