Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

Conditions

• Bowel Preparation

Eligibility Criteria

Sex

ALL

Age

12 Months - 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). MIRALAX is mixed with non-carbonated, clear beverage, or water and consumed at specified intervals until the total required dose.
• SENNA — DRUG
  SENNA 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.

Study Details

Bowel preparation for pediatric colonoscopy.

Key Dates

First listed

Oct 2, 2019

Start date

Jun 23, 2022

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

39 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+SENNA
  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+SENNA
  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.
• Experimental: Participants aged 12 months to <2 years: CLENPIQ
  CLENPIQ administered using "split-dose" method and consists of two separate doses: the first dose (1/4 bottle \[approximately 40 mL\]) one day before colonoscopy between 5:00 PM and 9:00 PM, and the second dose (1/4 bottle \[approximately 40 mL\]) 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 12 months to <2 years: MIRALAX+SENNA
  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)

Find similar trials in Mobile, AL