A Randomized, Assessor-Blind, Parallel-Groups, Multicenter Trial Assessing the Safety and Efficacy, Including Pharmacokinetic Assessments, of CLENPIQ in Children Aged 2 Years to Less Than 9 Years
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Bowel preparation for pediatric colonoscopy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 8
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Ferring Investigational Site
RECRUITING
Mobile
California
Ferring Investigational Site
RECRUITING
San Diego
Maryland
Ferring Investigational Site
RECRUITING
Baltimore
Ferring Investigational Site
RECRUITING
Baltimore
New York
Ferring Investigational Site
RECRUITING
The Bronx
Contact Information
Primary
Global Clinical Compliance
DK0-Disclosure@ferring.com
+1 833-548-1402 (US/Canada)
Backup
Global Clinical Compliance
DK0-Disclosure@ferring.com
+1 862-286-5200 (outside US)
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
Experimental: Participants aged 2 to <4 years: CLENPIQ
CLENPIQ administered using split-dose method and consists of two separate doses: the first dose (½ bottle \[approximately 80 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL.
Active_comparator: Participants aged 2 to <4 years: MIRALAX
MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 4 ounce (oz) for every 30 minutes, one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.
Experimental: Participants aged 4 to <9 years: CLENPIQ
CLENPIQ administered using split-dose method and consists of two separate doses: the first dose (1 bottle \[approximately 160 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (½ bottle \[approximately 80 mL\]) the next day, at least 5 hours prior but no more than 9 hours prior to the colonoscopy. Following each dose, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.
Active_comparator: Participants aged 4 to <9 years: MIRALAX
MIRALAX 3.4 to 4.9 g/kg up to a maximum of 238 g is reconstituted with non-carbonated, clear beverage, or water and administered in increments of 8 oz for every 30 minutes one day before colonoscopy between 5:00 PM and 9:00 PM. Following dosing, participants will consume 50 mL/kg of clear liquids, up to a limit of 1,000 mL total weight-based maximum.
Related Therapeutic Areas
Sponsors
Leads: Ferring Pharmaceuticals