Recruiting
Phase 1
Phase 2

CLENPIQ

Sponsor:

Ferring Pharmaceuticals

Code:

NCT04113382

Conditions

Bowel Preparation

Eligibility Criteria

Sex: All

Age: 1 - 8

Healthy Volunteers: Not accepted

Interventions

CLENPIQ

MIRALAX

SENNA

Study Details

Brief summary:

Bowel preparation for pediatric colonoscopy.

Conditions

Bowel Preparation

Study ID

NCT04113382

Start date

Jun 23, 2022

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 8

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Use of the following prohibited medication: lithium (within 48 hours prior to procedure), laxatives (within 24 hours prior to procedure), drugs that in the opinion of the investigator are causing constipation in the participant (within 48 hours prior to procedure), antidiarrheal drugs (within 72 hours prior to procedure), or oral iron preparations (within 1 week prior to procedure).
  • Participation in an interventional investigational trial requiring administration of an investigational drug within 30 days prior to receiving trial medication (or within 60 days for investigational drugs with an elimination half-life >15 days).
  • Any clinically relevant abnormal findings in medical history, physical examination, vital signs, electrocardiogram (ECG), clinical chemistry, hematology, coagulation, or urinalysis at screening which in the opinion of the investigator(s), might put the participant at risk because of his/her participation in the trial.
  • Hypersensitivity to any of the ingredients of the trial medications.
  • Inability to comply with the dietary restrictions in the trial or the fluid requirements before and after investigational medicinal product (IMP) administration.

Study Design

Enrollment

39 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

CLENPIQ

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

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

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.

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 and Locations

Central contacts

Ferring Pharmaceuticals

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

Locations

South Alabama Medical Science Foundation

Recruiting

Mobile, Alabama, United States, 36604

Rady Children's Hospital (San Diego)

Recruiting

San Diego, California, United States, 92123

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Johns Hopkins Children's Medical Center

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Ferring Pharmaceuticals

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Colon Cleansing
  • Preparation for Colonoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ferring Pharmaceuticals on 2026-09-04.