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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1135-2011 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Norgine BV | UNKNOWN |
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To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOVIPREP (Morning-only dose) | Experimental | 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. |
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| MOVIPREP (Split-dose) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOVIPREP | Drug | MOVIPREP solution |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day (the day of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alma-Ata | Kazakhstan | |||||
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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | MOVIPREP (Split-dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 day (the day of colonoscopy) |
| 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. | 1 day (the day of colonoscopy) |
| 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. | 1 day (the day of colonoscopy) |
| 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. | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. |
| Moscow |
| Russia |
| Saint Petersburg | Russia |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-treat population | Posted | Number | percentage of participants | 1 day (the day of colonoscopy) |
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| 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. | Intent-to-treat population with available VAS data. | Posted | Mean | Standard Deviation | units on a scale | 1 day (the day of colonoscopy) |
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| 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. | Intent-to-treat with available data | Posted | Mean | Standard Deviation | units on a scale | 1 day (the day of colonoscopy) |
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| 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. | Intent-to-treat population with available data | Posted | Mean | Standard Deviation | ml | 1 day (the day of colonoscopy) |
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| 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. | Safety population | Posted | Number | percentage of participants | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 70 | 41 | 70 | ||
| EG001 | 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. | 0 | 70 | 43 | 70 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastritis erosive | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Product taste abnormal | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood calcium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood calcium increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood chloride increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood iron decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Blood iron increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| C520497 | MoviPrep |
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| Male |
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| White |
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| Kazakhstan |
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