Trial Outcomes & Findings for Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep (NCT NCT01073943)

NCT ID: NCT01073943

Last Updated: 2012-10-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 603 participants
• Primary outcome timeframe: Day 2
• Results posted on: 2012-10-30

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	300	303
Overall Study Safety Population (Treated)	296	302
Overall Study Intent to Treat Population	294	300
Overall Study COMPLETED	287	295
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	8	2
Overall Study Protocol Violation	2	1
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	0	2
Overall Study Power outage; colonoscopy not done	1	0
Overall Study Subject forgot	0	1
Overall Study Unable to return for follow-up	0	1
Overall Study Could not tolerate prep	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PicoPrep n=296 Participants "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 n=302 Participants 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 n=598 Participants Total of all reporting groups
Age Continuous	56.8 years STANDARD_DEVIATION 9.66 • n=93 Participants	56.2 years STANDARD_DEVIATION 10.11 • n=4 Participants	56.5 years STANDARD_DEVIATION 9.89 • n=27 Participants
Sex: Female, Male Female	192 Participants n=93 Participants	189 Participants n=4 Participants	381 Participants n=27 Participants
Sex: Female, Male Male	104 Participants n=93 Participants	113 Participants n=4 Participants	217 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=93 Participants	15 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	288 Participants n=93 Participants	287 Participants n=4 Participants	575 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Asian	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race/Ethnicity, Customized Black or African American	22 participants n=93 Participants	32 participants n=4 Participants	54 participants n=27 Participants
Race/Ethnicity, Customized White	274 participants n=93 Participants	268 participants n=4 Participants	542 participants n=27 Participants
Race/Ethnicity, Customized Other	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Body Mass Index	29.185 kg/m^2 STANDARD_DEVIATION 5.3209 • n=93 Participants	29.541 kg/m^2 STANDARD_DEVIATION 6.1688 • n=4 Participants	29.365 kg/m^2 STANDARD_DEVIATION 5.7634 • n=27 Participants

PRIMARY outcome

Timeframe: Day 2

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

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.

Outcome measures

Measure	PicoPrep n=294 Participants "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 n=300 Participants 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.
Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist	83.0 percentage of participants	79.7 percentage of participants

SECONDARY outcome

Timeframe: Day 2

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

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.

Outcome measures

Measure	PicoPrep n=294 Participants "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 n=300 Participants 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.
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist	81.3 percentage of participants	84.0 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=293 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Very difficult	0 percentage of participants	5.7 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Very easy	58.4 percentage of participants	16.1 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Easy	29.0 percentage of participants	21.1 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Tolerable	11.6 percentage of participants	45.3 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? Difficult	1.0 percentage of participants	11.7 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=293 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? Yes	99.7 percentage of participants	92.3 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? No	0.3 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=292 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Excellent	45.5 percentage of participants	19.1 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Good	43.8 percentage of participants	48.7 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Fair	9.2 percentage of participants	25.5 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Poor	0.7 percentage of participants	3.4 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation Bad	0.7 percentage of participants	3.4 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=293 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Excellent	25.6 percentage of participants	4.0 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Good	48.1 percentage of participants	23.8 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Tolerable	23.9 percentage of participants	52.3 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Poor	1.7 percentage of participants	12.1 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was Bad	0.7 percentage of participants	7.7 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=293 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? Yes	93.2 percentage of participants	59.4 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? No	6.8 percentage of participants	40.6 percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.

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

Outcome measures

Measure	PicoPrep n=293 Participants "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 n=298 Participants 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.
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? No	95.2 percentage of participants	85.6 percentage of participants
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? Yes	4.8 percentage of participants	14.4 percentage of participants

SECONDARY outcome

Timeframe: up to one month

Population: Safety population of participants who were treated.

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.

Outcome measures

Measure	PicoPrep n=296 Participants "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 n=302 Participants 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.
Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE	218 participants	241 participants
Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to discontinuation of study drug	0 participants	1 participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Related TEAEs	33 participants	29 participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Deaths	0 participants	0 participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Serious AE	2 participants	1 participants
Participants With Treatment-Emergent Adverse Events (TEAEs) Severe TEAEs	5 participants	6 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 2

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

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.

Outcome measures

Measure	PicoPrep n=294 Participants "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 n=300 Participants 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.
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist Mid-colon	93.2 percentage of participants	88.7 percentage of participants
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist Recto-sigmoid colon	92.2 percentage of participants	89.0 percentage of participants
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist Overall: ascending, mid, and recto-sigmoid colon	78.9 percentage of participants	78.0 percentage of participants

Adverse Events

PicoPrep

Serious events: 2 serious events

Other events: 167 other events

Deaths: 0 deaths

HalfLytely

Serious events: 1 serious events

Other events: 194 other events

Deaths: 0 deaths

Serious adverse events

Measure	PicoPrep n=296 participants at risk "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 n=302 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.34% 1/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	0.00% 0/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Injury, poisoning and procedural complications Anastomatic complication	0.34% 1/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	0.00% 0/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Metabolism and nutrition disorders Dehydration	0.34% 1/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	0.00% 0/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Cardiac disorders Acute coronary syndrome	0.34% 1/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	0.00% 0/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Gastrointestinal disorders Ileus	0.00% 0/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	0.33% 1/302 • Treatment-emergent AEs occurring from Day 1 up to one month.

Other adverse events

Measure	PicoPrep n=296 participants at risk "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 n=302 participants at risk 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.
Gastrointestinal disorders Nausea	3.7% 11/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	5.3% 16/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	15.9% 47/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	18.9% 57/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Gastrointestinal disorders Colonic polyp	12.5% 37/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	15.6% 47/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Gastrointestinal disorders Diverticulum	21.3% 63/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	28.1% 85/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Gastrointestinal disorders Diverticulum intestinal	9.1% 27/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	7.6% 23/302 • Treatment-emergent AEs occurring from Day 1 up to one month.
Gastrointestinal disorders Haemorrhoids	28.7% 85/296 • Treatment-emergent AEs occurring from Day 1 up to one month.	26.8% 81/302 • Treatment-emergent AEs occurring from Day 1 up to one month.

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: DK0-Disclosure@ferring.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER