Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
ConditionBowel Preparation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-8
SponsorFerring Pharmaceuticals
About this trial
Bowel preparation for pediatric colonoscopy.
Eligibility criteria
Qualifiers
Male or female, aged 2 years to <9 years being scheduled to undergo elective colonoscopy.
Weight ≥10 kg (≥22 lbs).
Participants must have had an average of three or more spontaneous bowel movements (SBM) per week 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.
Clinically significant abdominal pain during the screening period.
Severe acute inflammatory bowel disease (IBD) during the screening period.
Trial design
Treatments tested in this trial
- CLENPIQ
- MIRALAX
Treatment groups
30 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov