The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
296
State Healthcare Institution Municipal Clinical Hospital No. 31 of Moscow
Moscow, Russia
Federal State Budgetary Institution "State Scientifical Center of Coloproctology"
Moscow, Russia
State Healthcare Institution of Yaroslavl Region "Regional Clinical Cancer Hospital"
Yaroslavl, Russia
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (\<= 65; \> 65), gender and inflammatory bowel disease (IBD) status.
Time frame: Colonoscopy was performed on Day 2.
Mean BBPS Score by Segment and Globally (ITT Population)
The mean global BBPS scores and scores by colon segment are presented for the ITT population. For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts: * unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0 * portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1 * minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2 * entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3. The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately.
Time frame: Colonoscopy was performed on Day 2.
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Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented. For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows: * unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0 * portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1 * minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2 * entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3. Reconciled scores were based on the 3 blinded reviews.
Time frame: Colonoscopy was performed on Day 2.
The Percentage of Patients in Whom Lesions Were Detected.
The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented.
Time frame: Colonoscopy was performed on Day 2.
The Percentage of Patients for Whom the Colonoscopy Was Completed
The percentage of patients for whom a total colonoscopy could be completed is presented.
Time frame: Colonoscopy was performed on Day 2.
Mean Colonoscopy Duration
The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes.
Time frame: Colonoscopy was performed on Day 2.
Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator. The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows: * presence of faeces and soiled fluid: investigation could not be reliably performed = 0 * presence of faecal material and of unclear fluid, with negative effect on the reliability of the investigation = 1 * brown liquid, no solid faecal material, presence of unclear residual fluid that could be aspirated: no effect on the reliability of the investigation = 2 * absence of solid faecal material, presence of clear residual fluid = 3 * no faecal material, no residual fluid, empty colon = 4.
Time frame: Colonoscopy was performed on Day 2.
Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment
Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment. A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented.
Time frame: Study treatment was administered as a split-dose on Days 1 and 2.