Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
ConditionBowel Preparation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-8
SponsorFerring Pharmaceuticals
About this trial
Bowel preparation for pediatric colonoscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 12 months to <9 years being scheduled to undergo elective colonoscopy.
Weight ≥10 kg (≥22 lbs).
Participants must have had regular spontaneous bowel movements (SBM) weekly for 1 month prior to the colonoscopy.
Written informed consent (by parent(s)/ caregiver(s)/ guardian(s)) and assent (if applicable) obtained at screening.
Disqualifiers
History of significant liver, cardiovascular, or renal disease (including recent or ongoing oliguria).
Acute surgical abdominal conditions (e.g., acute obstruction or perforation) during the screening period.
Concern for obstipation or fecal impaction.
Severe acute inflammatory bowel disease (IBD) defined as subjects with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score >65 or a Short Pediatric Crohn's Disease Activity Index (short PCDAI) score >40, at the time of screening, or development of severe IBD between (Visit 1) and investigational medicinal product (IMP) dispensation (Visit 2).
Trial design
Design model
Parallel
Treatments tested in this trial
CLENPIQ
DrugCLENPIQ consists of sodium picosulfate 10.0 mg + magnesium oxide 3.5 g + citric acid, anhydrous 12.0 g. Supplied as a pre-mixed, ready-to-drink oral solution in two bottles, each containing 160 mL.
MIRALAX
DrugMIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol \[PEG\] 3350). MIRALAX is mixed with non-carbonated, clear beverage, or water and consumed at specified intervals until the total required dose.
SENNA
DrugSENNA Liquid (chocolate flavor) is an oral solution to be taken according to body weight (8.8 mg for 10-22 kg, 17.6 mg for 22-34 kg and 26.4 mg for \>34 kg) prior to MIRALAX.
Treatment groups
39 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Participants aged 2 to <4 years: CLENPIQExperimental treatment 1 intervention
Group B: Participants aged 2 to <4 years: MIRALAX+SENNAActive comparator 2 interventions
Group C: Participants aged 4 to <9 years: CLENPIQExperimental treatment 1 intervention
Group D: Participants aged 4 to <9 years: MIRALAX+SENNAActive comparator 2 interventions
Group E: Participants aged 12 months to <2 years: CLENPIQExperimental treatment 1 intervention
Group F: Participants aged 12 months to <2 years: MIRALAX+SENNAActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale
The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Time frame
On the day of colonoscopy (Day 1)Secondary outcomes
1
Percentage of participants classified as "excellent" in the Modified Aronchick scale
The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). Percentage of participants classified as "excellent" in the Modified Aronchick scale will be reported.
Time frame
On the day of colonoscopy (Day 1)2
Percentage of participants who completed the assigned dose of CLENPIQ among participants in whom nasogastric tube was not utilized to assist with CLENPIQ dosing
A nasogastric tube may be inserted if the participant is likely to fail to drink the prescribed amount of cleanout preparation within the required time. Percentage of participants who completed the assigned dose of CLENPIQ without utilizing nasogastric tube will be reported.
Time frame
From randomization (Day -1) up to second dose of CLENPIQ (Day 1)3
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How easy was it for you/the child to drink the bowel cleanout medicine?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very easy, 2=easy, 3=okay, 4=difficult, 5=very difficult, 6=do not know).
Time frame
On the day of colonoscopy (Day 1)4
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very well, 2=well, 3=okay, 4=bad, 5=very bad, 6=do not know).
Time frame
On the day of colonoscopy (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov