Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Conditions

• Bowel Preparation

Eligibility Criteria

Sex

ALL

Age

2 Years - 8 Years

Healthy Volunteers

Not accepted

Interventions

• CLENPIQ — DRUG
  CLENPIQ 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 — DRUG
  MIRALAX powder for oral solution, supplied in a 8.3 oz multi-dose bottle containing 238 g of laxative powder (polyethylene glycol \[PEG\] 3350).

Study Details

Bowel preparation for pediatric colonoscopy.

Key Dates

Start date

Jun 23, 2022

Status verified

Aug 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• 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.

Primary Outcome Measure

Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale [ Time Frame: On the day of colonoscopy (Day 1) ]

Central Contacts

• Global Clinical Compliance
  +1 833-548-1402 (US/Canada)
  [email protected]
• Global Clinical Compliance
  +1 862-286-5200 (outside US)
  [email protected]

Locations (5)

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