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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01073943

First received: February 22, 2010

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

Results First Received: August 10, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bowel Preparation
Interventions:	Drug: PicoPrep Drug: HalfLytely Drug: bisacodyl

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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
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.

Participant Flow: Overall Study

	PicoPrep	HalfLytely
STARTED	300	303
Safety Population (Treated)	296	302
Intent to Treat Population	294 ^[1]	300 ^[1]
COMPLETED	287	295
NOT COMPLETED	13	8
Withdrawal by Subject	8	2
Protocol Violation	2	1
Adverse Event	1	1
Lost to Follow-up	0	2
Power outage; colonoscopy not done	1	0
Subject forgot	0	1
Unable to return for follow-up	0	1
Could not tolerate prep	1	0

[1]	Two treated participants did not have an efficacy assessment performed.

Baseline Characteristics

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Reporting Groups

	Description
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
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.
Total	Total of all reporting groups

Baseline Measures

	PicoPrep	HalfLytely	Total
Number of Participants [units: participants]	296	302	598
Age [units: years] Mean ± Standard Deviation	56.8 ± 9.66	56.2 ± 10.11	56.5 ± 9.89
Gender [units: participants]
Female	192	189	381
Male	104	113	217
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	8	15	23
Not Hispanic or Latino	288	287	575
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	0	1	1
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	22	32	54
White	274	268	542
Other	0	0	0
Body Mass Index [units: kg/m^2] Mean ± Standard Deviation	29.185 ± 5.3209	29.541 ± 6.1688	29.365 ± 5.7634

Outcome Measures

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1. Primary:

Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist [ Time Frame: Day 2 ]

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2. 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 [ Time Frame: Day 2 ]

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3. Secondary:

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? [ Time Frame: Day 2 ]

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Measure Type	Secondary
Measure Title	Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?
Measure Description	Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
Time Frame	Day 2
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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
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.

Measured Values

	PicoPrep	HalfLytely
Number of Participants Analyzed [units: participants]	293	298
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? [units: percentage of participants]
Very easy	58.4	16.1
Easy	29.0	21.1
Tolerable	11.6	45.3
Difficult	1.0	11.7
Very difficult	0	5.7

Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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4. Secondary:

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? [ Time Frame: Day 2 ]

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5. Secondary:

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation [ Time Frame: Day 2 ]

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6. Secondary:

Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was [ Time Frame: Day 2 ]

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7. 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? [ Time Frame: Day 2 ]

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8. 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? [ Time Frame: Day 2 ]

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9. Secondary:

Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: up to one month ]

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10. 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 [ Time Frame: Day 2 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01073943 History of Changes
Other Study ID Numbers:	2009-02
Study First Received:	February 22, 2010
Results First Received:	August 10, 2012
Last Updated:	October 23, 2012
Health Authority:	United States: Food and Drug Administration

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