Trial Outcomes & Findings for Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation (NCT NCT01732692)

Last Updated: 2014-05-15

Results Overview

Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

1 day (the day of colonoscopy)

Results posted on

2014-05-15

Participant Flow

Participants took part in the study at 6 investigative sites in the Russian Federation and the Republic of Kazakhstan from 22 November 2012 to 5 April 2013.

Participants indicated for a colonoscopy were enrolled equally in 1 of 2 treatment groups, morning-only on the day of the clinical procedure or split-dosing in 2 stages with a nocturnal pause.

Participant milestones

Participant milestones
Measure	MOVIPREP (Morning-only Dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Overall Study STARTED	70	70
Overall Study COMPLETED	70	69
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MOVIPREP (Morning-only Dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Overall Study Adverse Event	0	1

Baseline Characteristics

Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.	Total n=140 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 17.41 • n=5 Participants	49.1 years STANDARD_DEVIATION 16.26 • n=7 Participants	49.8 years STANDARD_DEVIATION 16.79 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	55 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	15 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized White	64 participants n=5 Participants	66 participants n=7 Participants	130 participants n=5 Participants
Height	171.1 cm STANDARD_DEVIATION 9.36 • n=5 Participants	165.1 cm STANDARD_DEVIATION 7.83 • n=7 Participants	168.1 cm STANDARD_DEVIATION 9.07 • n=5 Participants
Weight	73.5 kg STANDARD_DEVIATION 16.92 • n=5 Participants	68.3 kg STANDARD_DEVIATION 13.86 • n=7 Participants	71.1 kg STANDARD_DEVIATION 15.75 • n=5 Participants
Body Mass Index (BMI)	25.1 kg/m^2 STANDARD_DEVIATION 5.30 • n=5 Participants	25.1 kg/m^2 STANDARD_DEVIATION 5.10 • n=7 Participants	25.1 kg/m^2 STANDARD_DEVIATION 5.25 • n=5 Participants
Region of Enrollment Russia	57 participants n=5 Participants	63 participants n=7 Participants	120 participants n=5 Participants
Region of Enrollment Kazakhstan	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day (the day of colonoscopy)

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Percentage of Participants With Successful Colon Cleansing	94.29 percentage of participants	91.43 percentage of participants

SECONDARY outcome

Timeframe: 1 day (the day of colonoscopy)

Population: Intent-to-treat population with available VAS data.

Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant.

Outcome measures

Outcome measures
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=69 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Patient Satisfaction of Colonoscopy Preparation (VAS)	81.2 units on a scale Standard Deviation 20.97	79.6 units on a scale Standard Deviation 23.18

SECONDARY outcome

Timeframe: 1 day (the day of colonoscopy)

Population: Intent-to-treat with available data

Compliance score = 100 \* (total amount MOVIPREP® intake) / (planned MOVIPREP intake). Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre.

Outcome measures

Outcome measures
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=69 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Total Compliance Score	98.1 units on a scale Standard Deviation 6.10	99.5 units on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: 1 day (the day of colonoscopy)

Population: Intent-to-treat population with available data

To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.

Outcome measures

Outcome measures
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=69 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Patient Compliance - Amount of Additional Clear Liquid Consumed After first liter of study drug	545.43 ml Standard Deviation 128.6	640.29 ml Standard Deviation 243.4
Patient Compliance - Amount of Additional Clear Liquid Consumed After second liter of study drug	539.71 ml Standard Deviation 116.5	585.65 ml Standard Deviation 145.2

SECONDARY outcome

Timeframe: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.

Population: Safety population

An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.

Outcome measures

Outcome measures
Measure	MOVIPREP (Morning-only Dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=70 Participants MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Percentage of Patients Who Experienced Adverse Events (AEs) Any adverse event (AE)	58.6 percentage of participants	61.4 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) Mild adverse event	52.9 percentage of participants	54.3 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) Moderate adverse event	5.7 percentage of participants	7.1 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) Severe adverse event	0.0 percentage of participants	0.0 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) Serious adverse event	0.0 percentage of participants	0.0 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) AE leading to study discontinuation	0.0 percentage of participants	1.4 percentage of participants
Percentage of Patients Who Experienced Adverse Events (AEs) Treatment-related adverse event	57.1 percentage of participants	58.6 percentage of participants

Adverse Events

MOVIPREP (Morning-only Dose)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

MOVIPREP (Split-dose)

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Director

Takeda

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER

Measure	MOVIPREP (Morning-only Dose) n=70 participants at risk MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.	MOVIPREP (Split-dose) n=70 participants at risk MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
Gastrointestinal disorders Abdominal discomfort	18.6% 13/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	37.1% 26/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 5/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal tenderness	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 2/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastritis erosive	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	42.9% 30/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	31.4% 22/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	7.1% 5/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 7/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Product taste abnormal	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.3% 3/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Respiratory Tract Infection	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	4.3% 3/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	4.3% 3/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood calcium decreased	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood calcium increased	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood chloride increased	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatinine increased	4.3% 3/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood glucose increased	4.3% 3/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood iron decreased	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 5/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood iron increased	2.9% 2/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Body temperature increased	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.4% 1/70 • From the first dose of study drug until the end of the colonoscopy, maximum of 24 hours. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.