The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight \>40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
250
Oral solution taken the evening before the colonoscopy
Oral solution taken the evening before the colonoscopy
Fakultní nemocnice Královské Vinohrady
Prague, Czechia
Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale)
Blinded overall assessment of preparation efficacy (Cleansing Score) was determined by the colonoscopist upon completion of the examination, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. Only perfect preparations graded as excellent (4) or good (3), which allowed full, reliable examination of the mucosa were considered as successful. The adjusted percentage of subjects with a successful preparation was determined using a logistic regression model, including treatment and country as covariates.
Time frame: At Day 2 (colonoscopy visit)
Mean Colon Cleansing Score (4-point Scale)
The Cleansing Score was determined by the blinded colonoscopist, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. The adjusted mean score was estimated using a 2-way analysis of variance (ANOVA), including treatment and country as covariates.
Time frame: At Day 2 (colonoscopy visit)
Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
The BBPS score for each colon segment (left, transverse, right) was determined by the blinded colonoscopist as follows: * 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared * 1 = Portion of mucosa of the segment seen, but other areas of the colon segment 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. Each segment score ranged from 0-3. Global score was sum of the 3 segment scores and ranged from 0-9 (worst to best). Successful colon cleansing was defined as a global BBPS score ≥6. The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.
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Všeobecná fakultní nemocnice v Praze
Prague, Czechia
Université de Picardie Jules Verne
Amiens, France
Hôpital Femme Mère-Enfant
Bron, France
Hôpital Necker Enfants Malades
Paris, France
Uniklinikum Essen
Essen, Germany
Evang Krankenhaus Hamm
Hamm, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
Leipzig, Germany
Klinikum Ulm
Ulm, Germany
HELIOS Klinikum Wuppertal
Wuppertal, Germany
...and 14 more locations
Time frame: At Day 2 (colonoscopy visit)
Percentage of Subjects With Need for Rescue Treatment
The percentage of subjects who needed rescue treatment (saline enema) prior to colonoscopy because of inadequate preparation intake was assessed.
Time frame: At Day 2 (colonoscopy visit, before colonoscopy)
Percentage of Subjects With Need for Nasogastric Tube To Complete Preparation
The percentage of subjects who needed placement of a nasogastric tube to achieve administration of the complete preparation was assessed.
Time frame: At Day 1 (treatment visit)
Percentage of Subjects With Colonoscopy Procedure Documented as Completed
The percentage of subjects with a complete colonoscopy, defined as a procedure that reached the caecum, was assessed.
Time frame: At Day 2 (colonoscopy visit)
Median Time to Caecal Intubation
The time to caecal intubation was defined as the time from colonoscope introduction to caecal intubation, estimated using the Kaplan-Meier product limit method. In the event the procedure did not reach the caecum, the subject was censored at time of withdrawal of colonoscope.
Time frame: From colonoscope introduction to caecal intubation, assessed on Day 2 (colonoscopy visit)
Mean Duration of Examination
The duration of examination for colonoscopy (in minutes) was measured by the difference between the time of caecum intubation and the time of withdrawal of the colonoscope. The adjusted mean duration of examination was estimated using a 2-way ANOVA, including treatment and country as covariates. Subjects for whom the caecum was not reached were excluded from the analysis.
Time frame: From caecum intubation to withdrawal of the colonoscope, assessed on Day 2 (colonoscopy visit)
Mean Score for Overall Treatment Acceptability, Assessed Using Treatment Acceptability Questionnaire
The Treatment Acceptability Questionnaire was completed by the caregiver or subject after the subject ended the intake of preparation. Subject acceptability was rated as follows: * 1 = Very badly accepted/unacceptable * 2 = Badly but accepted * 3 = Neither good nor bad * 4 = Well accepted * 5 = Very well accepted. Overall acceptability score is the average of scores from the 2 doses ranging from 1 - 5 (worst to best). The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.
Time frame: At Day 1 (treatment visit)
Mean Overall Treatment Compliance
Treatment compliance according the instructions of use provided in the prescription was assessed as the percentage of volume of fluid taken relative to the planned volume of fluid to be taken (measured by the caregiver and reported in the treatment questionnaire of subject's leaflet during treatment administration). Overall treatment compliance was derived from the total volumes of fluid (i.e. preparation + hydration for Eziclen®/Izinova® and preparation only for Klean-Prep®) and was assessed for dose 1, dose 2 and globally (accounting for both doses). The adjusted mean overall treatment compliance (%) was estimated using a 2-way ANOVA, including treatment and country as covariates.
Time frame: At Day 1 (treatment visit)
Mean Subject Tolerability Total Score, Assessed Using a Symptom Scale
Tolerability was assessed using a Symptom Scale after each dose of treatment for stomach cramping, stomach bloating and nausea on a paediatric 5-point scale as follows: * 1 = No symptom * 2 = Mild * 3 = Bothersome * 4 = Distressing * 5 = Severely distressing symptoms. The total tolerability score is the sum of the scores for the 3 symptoms ranging from 3 to 15 (best to worst). Mean total tolerability scores after dose 1 and dose 2 are presented.
Time frame: At Day 1 (treatment visit)