Trial Outcomes & Findings for Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep (NCT NCT01073930)
NCT ID: NCT01073930
Last Updated: 2013-02-12
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
608 participants
Primary outcome timeframe
Day 2
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to 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
|
307
|
301
|
|
Overall Study
Safety Population (Treated)
|
305
|
298
|
|
Overall Study
Intent to Treat Population
|
304
|
297
|
|
Overall Study
COMPLETED
|
304
|
295
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to 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
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Noncompliance with study drug
|
0
|
1
|
|
Overall Study
Inadequate prep; unable to do procedure
|
0
|
1
|
Baseline Characteristics
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
Baseline characteristics by cohort
| Measure |
PICOPREP
n=305 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to 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.
|
Total
n=603 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.8 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.00 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
298 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
591 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 participants
n=5 Participants
|
27 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
265 participants
n=5 Participants
|
268 participants
n=7 Participants
|
533 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.4 kg/m^2
STANDARD_DEVIATION 5.68 • n=5 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.34 • n=7 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2Population: 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=304 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=297 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
|
84.2 percentage of participants
|
74.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: 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 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=304 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=297 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) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Ascending colon
|
89.5 percentage of participants
|
78.8 percentage of participants
|
|
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Mid colon
|
92.4 percentage of participants
|
85.9 percentage of participants
|
|
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Recto-sigmoid colon
|
92.4 percentage of participants
|
87.2 percentage of participants
|
|
Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist
Overall: ascending, mid, and recto-sigmoid colon
|
86.8 percentage of participants
|
75.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: 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=302 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=296 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 easy
|
57.9 percentage of participants
|
8.1 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
|
31.5 percentage of participants
|
20.9 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
|
9.6 percentage of participants
|
47.0 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
|
14.9 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 difficult
|
0 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two 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=303 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=296 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
|
99.0 percentage of participants
|
89.9 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?
No
|
1.0 percentage of participants
|
10.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: 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=301 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=296 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
|
46.8 percentage of participants
|
16.6 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Good
|
45.2 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Fair
|
6.6 percentage of participants
|
28.7 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Poor
|
1.0 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Bad
|
0.3 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant 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=303 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=297 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
|
23.4 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Good
|
50.5 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Tolerable
|
25.7 percentage of participants
|
56.2 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Poor
|
0.3 percentage of participants
|
13.1 percentage of participants
|
|
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was
Bad
|
0 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: 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=302 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=296 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
|
96.0 percentage of participants
|
54.7 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
|
4.0 percentage of participants
|
45.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2Population: 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 2-point scale: yes, no
Outcome measures
| Measure |
PICOPREP
n=301 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=296 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?
Yes
|
1.7 percentage of participants
|
13.5 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?
No
|
98.3 percentage of participants
|
86.5 percentage of participants
|
SECONDARY outcome
Timeframe: up to one monthPopulation: 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=305 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to 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.
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
211 participants
|
217 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Death
|
0 participants
|
0 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious AE
|
1 participants
|
2 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)
Severe TEAEs
|
2 participants
|
6 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
Related TEAEs
|
19 participants
|
26 participants
|
Adverse Events
PICOPREP
Serious events: 1 serious events
Other events: 166 other events
Deaths: 0 deaths
HalfLytely
Serious events: 2 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PICOPREP
n=305 participants at risk
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=298 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
Pancreatitis acute
|
0.33%
1/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
0.00%
0/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
0.34%
1/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
0.34%
1/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
Other adverse events
| Measure |
PICOPREP
n=305 participants at risk
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
|
HalfLytely
n=298 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
Colonic polyp
|
17.0%
52/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
17.1%
51/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
Gastrointestinal disorders
Diverticulum
|
19.7%
60/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
24.2%
72/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
3.6%
11/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
5.4%
16/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
Gastrointestinal disorders
Haemorrhoids
|
17.7%
54/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
19.8%
59/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
18.4%
56/305 • Treatment-emergent AEs occurring from Day 1 up to one month
|
17.1%
51/298 • Treatment-emergent AEs occurring from Day 1 up to one month
|
Additional Information
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