Trial Outcomes & Findings for Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose (NCT NCT03315949)

NCT ID: NCT03315949

Last Updated: 2020-08-13

Results Overview

Primary endpoint=Successful bowel cleansing (all segmental score 2 or above) \* Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate 1. poor 2. good 3. excellent

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 352 participants
• Primary outcome timeframe: Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal
• Results posted on: 2020-08-13

Participant Flow

Participant milestones

Measure	Same-day Dose Group Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy	Split-dose Group Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Overall Study STARTED	176	176
Overall Study COMPLETED	171	166
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose

Baseline characteristics by cohort

Measure	Same-day Dose Group n=172 Participants Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy	Split-dose Group n=167 Participants Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy	Total n=339 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	122 Participants n=7 Participants	244 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants	45 Participants n=7 Participants	95 Participants n=5 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	58.4 years STANDARD_DEVIATION 9.4 • n=7 Participants	58.0 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	72 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	95 Participants n=7 Participants	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants	167 Participants n=7 Participants	339 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
Region of Enrollment South Korea	172 participants n=5 Participants	167 participants n=7 Participants	339 participants n=5 Participants

PRIMARY outcome

Timeframe: Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal

Primary endpoint=Successful bowel cleansing (all segmental score 2 or above)

• Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate

1. poor

2. good

3. excellent

Outcome measures

Measure	Same-day Dose Group n=171 Participants Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy	Split-dose Group n=166 Participants Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Boston Bowel Preparation Scale	169 Number of successful cleansing	163 Number of successful cleansing

Adverse Events

Same-day Dose Group

Serious events: 0 serious events

Other events: 73 other events

Deaths: 0 deaths

Split-dose Group

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Same-day Dose Group n=172 participants at risk Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy	Split-dose Group n=167 participants at risk Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy. Polyethylene Glycol (PEG): Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Gastrointestinal disorders Adverse events related to bowel cleanser	23.8% 41/172 • Number of events 41 • Adverse events were collected between enrollment and 4 weeks of procedure	19.8% 33/167 • Number of events 33 • Adverse events were collected between enrollment and 4 weeks of procedure
Gastrointestinal disorders Adverse events related to bowel cleansing agent	9.3% 16/172 • Number of events 16 • Adverse events were collected between enrollment and 4 weeks of procedure	12.0% 20/167 • Number of events 20 • Adverse events were collected between enrollment and 4 weeks of procedure
Nervous system disorders Adverse events related to bowel cleansing agent	4.7% 8/172 • Number of events 8 • Adverse events were collected between enrollment and 4 weeks of procedure	5.4% 9/167 • Number of events 9 • Adverse events were collected between enrollment and 4 weeks of procedure

Additional Information

Dr. Tae-Geun Gweon

College of Medicine, The Catholic University of Korea

Phone: 82 32 340 2228

Email: gweontae@naver.com

Results disclosure agreements

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