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
Qualifiers
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
Treatments tested in this trial
- CLENPIQ
- MIRALAX
- SENNA
Treatment groups
39 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov