Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Conditions
Keywords
Bowel preparation, MOVIPREP®
Brief summary
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
Detailed description
All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy. The study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum. There is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.
Interventions
DRUGMOVIPREP
MOVIPREP solution
Sponsors
Norgine BV
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* male or female ≥18 years and ≤ 85 years * colonoscopy procedure indicated * willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion * willing and able to undergo study-related procedures * informed consent signed by a patient for participation in the study * negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study
Exclusion criteria
* ileus * suspected colonic tumor with manifestations of intestinal obstruction * delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation * toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis * suspected intestinal perforation or risk of gastrointestinal perforation * signs of severe intestinal bleeding * acute inflammatory anal or perianal pathology * severe concomitant diseases of internal organs * psychiatric diseases in aggravation stage * hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation * phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency * unconsciousness * dehydration * severe inflammatory diseases * acute abdominal pain of unknown etiology * pregnancy and lactation period * participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial * patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC) * any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Successful Colon Cleansing | 1 day (the day of colonoscopy) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction of Colonoscopy Preparation (VAS) | 1 day (the day of colonoscopy) | 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. |
| Total Compliance Score | 1 day (the day of colonoscopy) | 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. |
| Patient Compliance - Amount of Additional Clear Liquid Consumed | 1 day (the day of colonoscopy) | 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. |
| Percentage of Patients Who Experienced Adverse Events (AEs) | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. | 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. |
Countries
Kazakhstan, Russia
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 70 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | MOVIPREP (Morning-only Dose) | MOVIPREP (Split-dose) | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 17.41 | 49.1 years STANDARD_DEVIATION 16.26 | 49.8 years STANDARD_DEVIATION 16.79 |
| Body Mass Index (BMI) | 25.1 kg/m^2 STANDARD_DEVIATION 5.3 | 25.1 kg/m^2 STANDARD_DEVIATION 5.1 | 25.1 kg/m^2 STANDARD_DEVIATION 5.25 |
| Height | 171.1 cm STANDARD_DEVIATION 9.36 | 165.1 cm STANDARD_DEVIATION 7.83 | 168.1 cm STANDARD_DEVIATION 9.07 |
| Race/Ethnicity, Customized Asian | 6 participants | 4 participants | 10 participants |
| Race/Ethnicity, Customized White | 64 participants | 66 participants | 130 participants |
| Region of Enrollment Kazakhstan | 13 participants | 7 participants | 20 participants |
| Region of Enrollment Russia | 57 participants | 63 participants | 120 participants |
| Sex: Female, Male Female | 38 Participants | 55 Participants | 93 Participants |
| Sex: Female, Male Male | 32 Participants | 15 Participants | 47 Participants |
| Weight | 73.5 kg STANDARD_DEVIATION 16.92 | 68.3 kg STANDARD_DEVIATION 13.86 | 71.1 kg STANDARD_DEVIATION 15.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 70 | 43 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Percentage of Participants With Successful Colon Cleansing
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.
Time frame: 1 day (the day of colonoscopy)
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MOVIPREP (Morning-only Dose) | Percentage of Participants With Successful Colon Cleansing | 94.29 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Participants With Successful Colon Cleansing | 91.43 percentage of participants |
p-value: <0.001Exact Farrington - Manning
Secondary
Patient Compliance - Amount of Additional Clear Liquid Consumed
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.
Time frame: 1 day (the day of colonoscopy)
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOVIPREP (Morning-only Dose) | Patient Compliance - Amount of Additional Clear Liquid Consumed | After second liter of study drug | 539.71 ml | Standard Deviation 116.5 |
| MOVIPREP (Morning-only Dose) | Patient Compliance - Amount of Additional Clear Liquid Consumed | After first liter of study drug | 545.43 ml | Standard Deviation 128.6 |
| MOVIPREP (Split-dose) | Patient Compliance - Amount of Additional Clear Liquid Consumed | After first liter of study drug | 640.29 ml | Standard Deviation 243.4 |
| MOVIPREP (Split-dose) | Patient Compliance - Amount of Additional Clear Liquid Consumed | After second liter of study drug | 585.65 ml | Standard Deviation 145.2 |
Secondary
Patient Satisfaction of Colonoscopy Preparation (VAS)
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.
Time frame: 1 day (the day of colonoscopy)
Population: Intent-to-treat population with available VAS data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOVIPREP (Morning-only Dose) | Patient Satisfaction of Colonoscopy Preparation (VAS) | 81.2 units on a scale | Standard Deviation 20.97 |
| MOVIPREP (Split-dose) | Patient Satisfaction of Colonoscopy Preparation (VAS) | 79.6 units on a scale | Standard Deviation 23.18 |
Secondary
Percentage of Patients Who Experienced Adverse Events (AEs)
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.
Time frame: From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Mild adverse event | 52.9 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Moderate adverse event | 5.7 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Serious adverse event | 0.0 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Any adverse event (AE) | 58.6 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Severe adverse event | 0.0 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | AE leading to study discontinuation | 0.0 percentage of participants |
| MOVIPREP (Morning-only Dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Treatment-related adverse event | 57.1 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Mild adverse event | 54.3 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Treatment-related adverse event | 58.6 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Moderate adverse event | 7.1 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Severe adverse event | 0.0 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Any adverse event (AE) | 61.4 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | Serious adverse event | 0.0 percentage of participants |
| MOVIPREP (Split-dose) | Percentage of Patients Who Experienced Adverse Events (AEs) | AE leading to study discontinuation | 1.4 percentage of participants |
Secondary
Total Compliance Score
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.
Time frame: 1 day (the day of colonoscopy)
Population: Intent-to-treat with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOVIPREP (Morning-only Dose) | Total Compliance Score | 98.1 units on a scale | Standard Deviation 6.1 |
| MOVIPREP (Split-dose) | Total Compliance Score | 99.5 units on a scale | Standard Deviation 2.66 |