Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy

NCT04113382 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 000359
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief Summary

Bowel preparation for pediatric colonoscopy.

Conditions

Bowel Preparation

Keywords

Colon Cleansing; Preparation for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale

  The efficacy of overall colon cleansing in terms of responders will be graded by a blinded endoscopist using the Modified Aronchick Scale. It is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.

  On the day of colonoscopy (Day 1)

Secondary Outcomes (15)

• Percentage of participants classified as "excellent" in the Modified Aronchick scale

  On the day of colonoscopy (Day 1)

• Percentage of participants who completed the assigned dose of CLENPIQ among participants in whom nasogastric tube was not utilized to assist with CLENPIQ dosing

  From randomization (Day -1) up to second dose of CLENPIQ (Day 1)

• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How easy was it for you/the child to drink the bowel cleanout medicine?

  On the day of colonoscopy (Day 1)

• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?

  On the day of colonoscopy (Day 1)

• Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did your/the child's tummy hurt since you/the child started the cleanout?

  On the day of colonoscopy (Day 1)

Study Arms (6)

Participants aged 2 to <4 years: CLENPIQ

EXPERIMENTAL

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.

Drug: CLENPIQ

Participants aged 2 to <4 years: MIRALAX+SENNA

ACTIVE COMPARATOR

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.

Drug: MIRALAX; Drug: SENNA

Participants aged 4 to <9 years: CLENPIQ

EXPERIMENTAL

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.

Drug: CLENPIQ

Participants aged 4 to <9 years: MIRALAX+SENNA

ACTIVE COMPARATOR

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.

Drug: MIRALAX; Drug: SENNA

Participants aged 12 months to <2 years: CLENPIQ

EXPERIMENTAL

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.

Drug: CLENPIQ

Participants aged 12 months to <2 years: MIRALAX+SENNA

ACTIVE COMPARATOR

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.

Drug: MIRALAX; Drug: SENNA

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.

Participants aged 12 months to <2 years: CLENPIQ; Participants aged 2 to <4 years: CLENPIQ; Participants aged 4 to <9 years: CLENPIQ

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.

Participants aged 12 months to <2 years: MIRALAX+SENNA; Participants aged 2 to <4 years: MIRALAX+SENNA; Participants aged 4 to <9 years: MIRALAX+SENNA

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.

Participants aged 12 months to <2 years: MIRALAX+SENNA; Participants aged 2 to <4 years: MIRALAX+SENNA; Participants aged 4 to <9 years: MIRALAX+SENNA

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Any prior colorectal surgery, excluding appendectomy and polyp removal.
• History of colon disease (e.g., Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome).
• History of or ongoing intestinal ulceration, toxic megacolon or other toxic colitis.
• History of upper gastrointestinal disorder (e.g., active ulcer, pyloric stenosis or other cause of gastric retention, gastroparesis, or ileus).
• History of upper gastrointestinal surgery (e.g., gastric resection or gastric bypass), excluding cholecystectomy.
• Chronic or persistent, severe nausea or vomiting during the screening period.
• Moderate to severe dehydration during the screening period.
• Prior history of epileptic reaction, convulsions, or seizures.
• Any clinically relevant neurological events with or without association with hyponatremia during the screening period.
• Serum creatinine, estimated glomerular filtration rate (eGFR), potassium, or sodium outside normal limits during the screening period.
• Hypermagnesemia during the screening period.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (5)

Ferring Investigational Site

Mobile, Alabama, 36604, United States

RECRUITING

Ferring Investigational Site

San Diego, California, 92123, United States

RECRUITING

Ferring Investigational Site

Baltimore, Maryland, 21201, United States

RECRUITING

Ferring Investigational Site

Baltimore, Maryland, 21287, United States

RECRUITING

Ferring Investigational Site

The Bronx, New York, 10467, United States

WITHDRAWN

MeSH Terms

Interventions

polyethylene glycol 3350

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Global Clinical Compliance

CONTACT

+1 833-548-1402 (US/Canada); DK0-Disclosure@ferring.com

Global Clinical Compliance

CONTACT

+1 862-286-5200 (outside US); DK0-Disclosure@ferring.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: June 23, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)