Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel. Clinical Trial
Official title:
Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda | Norgine BV |
Kazakhstan, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 ? and ?. | 1 day (the day of colonoscopy) | No |
| 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. | 1 day (the day of colonoscopy) | No |
| 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. |
1 day (the day of colonoscopy) | No |
| 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. | 1 day (the day of colonoscopy) | No |
| 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. | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. | Yes |