Trial Outcomes & Findings for A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy (NCT NCT02239692)

Last Updated: 2016-06-23

Results Overview

Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

204 participants

Primary outcome timeframe

Day 1 (day of colonoscopy)

Results posted on

2016-06-23

Participant Flow

Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to Jun 2015.

Participant milestones

Participant milestones
Measure	PICOPREP Day-before Dosing Schedule Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Overall Study STARTED	73	131
Overall Study Intention-to-treat Analysis Set	73	131
Overall Study Per-protocol Analysis Set	66	120
Overall Study Safety Analysis Set	70	125
Overall Study COMPLETED	67	118
Overall Study NOT COMPLETED	6	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PICOPREP Day-before Dosing Schedule Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Overall Study Incomplete colonoscopy	1	2
Overall Study Adverse Event	0	1
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	3	5
Overall Study Other reason	1	0

Baseline Characteristics

A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PICOPREP Day-before Dosing Schedule n=73 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=131 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	Total n=204 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	49 Participants n=5 Participants	85 Participants n=7 Participants	134 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	46 Participants n=7 Participants	70 Participants n=5 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 15.1 • n=5 Participants	58.4 years STANDARD_DEVIATION 13.3 • n=7 Participants	57.8 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	77 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	54 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	128 Participants n=7 Participants	199 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	130 Participants n=7 Participants	203 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (day of colonoscopy)

Population: The ITT analysis set consisted of all randomized subjects.

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=73 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=131 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale	8.2 score on a scale Standard Deviation 3.54	4.2 score on a scale Standard Deviation 3.75

PRIMARY outcome

Timeframe: Day 1 (day of colonoscopy)

Population: The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.

Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=66 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=120 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale	8.1 score on a scale Standard Deviation 3.38	3.7 score on a scale Standard Deviation 3.14

SECONDARY outcome

Timeframe: Day 1 (day of colonoscopy)

Population: The ITT analysis set consisted of all randomized subjects.

Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=73 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=131 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Ascending Colon Cleansing Responder Status (ITT)	15.1 percentage of subjects	61.1 percentage of subjects

SECONDARY outcome

Timeframe: From baseline (screening) up to day 10 after colonoscopy

Population: The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=70 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=125 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Frequency and Intensity of Adverse Events Frequency of all adverse events	4 subjects	15 subjects
Frequency and Intensity of Adverse Events Frequency of mild adverse events	4 subjects	12 subjects
Frequency and Intensity of Adverse Events Frequency of moderate adverse events	0 subjects	2 subjects
Frequency and Intensity of Adverse Events Frequency of severe adverse events	0 subjects	1 subjects

SECONDARY outcome

Timeframe: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

Population: The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.

Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=70 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=125 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) Clinically significant change in pulse	0 subjects	0 subjects
Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) Clinically significant change in blood pressure	0 subjects	0 subjects

SECONDARY outcome

Timeframe: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

Population: The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.

Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.

Outcome measures

Outcome measures
Measure	PICOPREP Day-before Dosing Schedule n=70 Participants Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=125 Participants Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) Clinically significant change in haematology	0 subjects	0 subjects
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) Clinically significant change in clinical chem	0 subjects	0 subjects
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) Clinically significant change in coagulation	0 subjects	0 subjects
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) Clinically significant change in urinalysis	0 subjects	0 subjects

Adverse Events

PICOPREP Day-before Dosing Schedule

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PICOPREP Tailored Dosing Schedule

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PICOPREP Day-before Dosing Schedule n=70 participants at risk Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=125 participants at risk Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).

Other adverse events

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

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

Measure	PICOPREP Day-before Dosing Schedule n=70 participants at risk Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution	PICOPREP Tailored Dosing Schedule n=125 participants at risk Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy. PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Congenital, familial and genetic disorders Gilbert's syndrome	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.00% 0/125 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Abdominal pain	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	4.0% 5/125 • Number of events 5 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Diarrhoea	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Nausea	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Anorectal discomfort	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Dyspepsia	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Eructation	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.00% 0/125 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Gastrointestinal disorders Vomiting	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
General disorders Malaise	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.00% 0/125 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Investigations Blood glucose increased	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Metabolism and nutrition disorders Hypercalcaemia	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.00% 0/125 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Nervous system disorders Headache	1.4% 1/70 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Psychiatric disorders Insomnia	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).
Psychiatric disorders Sleep disorder	0.00% 0/70 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).	0.80% 1/125 • Number of events 1 • Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).