Bowel PreparationPhase 1/2PICCOLONCT04113382
Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
A Phase 1/2 study testing CLENPIQ, MIRALAX and SENNA in people with Bowel Preparation, run by Ferring Pharmaceuticals at 4 sites in United States.
Trial summary
Bowel preparation for pediatric colonoscopy. Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- CLENPIQ, MIRALAX and SENNA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jun 2022to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
- Recruiting
Johns Hopkins Children's Medical Center
Baltimore, Maryland, 21287
- Recruiting
South Alabama Medical Science Foundation
Mobile, Alabama, 36604
- Recruiting
Rady Children's Hospital (San Diego)
San Diego, California, 92123
About this study
Official title: A Randomized, Assessor-Blind, Parallel-Groups, Multicenter Trial Assessing the Safety and Efficacy, Including Pharmacokinetic Assessments, of CLENPIQ in Children Aged 12 Months to Less Than 9 Years
Bowel preparation for pediatric colonoscopy.
- Conditions
- Bowel Preparation
- Being tested
- CLENPIQ, MIRALAX, SENNA
- Keywords
- Colon Cleansing, Preparation for Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLENPIQDrug
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.
MIRALAXDrug
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.
SENNADrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: MIRALAX; Drug: SENNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of colonoscopy (Day 1)
Secondary outcomes (15)
Percentage of participants classified as "excellent" 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). Percentage of participants classified as "excellent" in the Modified Aronchick scale will be reported.
Measured: 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
A nasogastric tube may be inserted if the participant is likely to fail to drink the prescribed amount of cleanout preparation within the required time. Percentage of participants who completed the assigned dose of CLENPIQ without utilizing nasogastric tube will be reported.
Measured: 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?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very easy, 2=easy, 3=okay, 4=difficult, 5=very difficult, 6=do not know).
Measured: 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?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=very well, 2=well, 3=okay, 4=bad, 5=very bad, 6=do not know).
Measured: 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?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Measured: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel fullness in your/the child's tummy since you/the child started the cleanout?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Measured: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child wake up last night?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Measured: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel sick to your/the child's stomach (nausea) since you/the child started the cleanout?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/ parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Measured: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How much were you/the child bothered by going to the bathroom since you/the child started the cleanout?
The tolerability and satisfaction of colon cleansing preparation for colonoscopy will be assessed by the child/parent(s)/caregiver(s)/guardian(s) using modified tolerability and satisfaction questionnaire. The above question will be answered on a 6-point scale: (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, 6=do not know).
Measured: On the day of colonoscopy (Day 1)
Systemic concentrations of picosulfate and bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM, active metabolite of picosulfate)
Measured: 3 to 6 hours after the second dose of CLENPIQ prior to colonoscopy (Day 1).
Systemic concentrations of magnesium at screening
At screening, PK assessments of magnesium concentrations will be performed for all participants.
Measured: Screening (≤21 days before scheduled colonoscopy)
Systemic concentrations of magnesium after randomization
After randomisation, PK assessments of magnesium concentrations will be performed only for the participants randomized to CLENPIQ.
Measured: 3 to 6 hours after second dose of CLENPIQ prior to colonoscopy (Day 1); 1 or 2 days after the colonoscopy (Day 2 or 3)
Percentage of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant participating in a clinical study.
Percentage of participants with any AE (serious or non-serious) will be presented.
Measured: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Percentage of participants with abnormal findings in vital signs
Percentage of participants with abnormal findings (clinically significant) in vital signs will be reported.
Measured: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Percentage of participants with abnormal findings in clinical laboratory tests
Percentage of participants with abnormal findings (clinically significant) in clinical laboratory tests will be reported.
Measured: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start23 Jun 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ferring Pharmaceuticals A/S, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113382
- Sponsor's protocol ID
- 000359
- Acronym
- PICCOLO
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2019
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Assessor-Blind, Parallel-Groups, Multicenter Trial Assessing the Safety and Efficacy, Including Pharmacokinetic Assessments, of CLENPIQ in Children Aged 12 Months to Less Than 9 Years
- ClinicalTrials.gov ID
- NCT04113382
- Acronym / sponsor ID
- PICCOLO / 000359
- Conditions
- Bowel Preparation
- Keywords
- Colon Cleansing, Preparation for Colonoscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bowel preparation for pediatric colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Participants aged 2 to <4 years: CLENPIQ | Experimental | Drug: CLENPIQCLENPIQ 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. |
| Participants aged 2 to <4 years: MIRALAX+SENNA | Active comparator | Drug: MIRALAX, Drug: SENNAMIRALAX 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. |
| Participants aged 4 to <9 years: CLENPIQ | Experimental | Drug: CLENPIQCLENPIQ 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. |
| Participants aged 4 to <9 years: MIRALAX+SENNA | Active comparator | Drug: MIRALAX, Drug: SENNAMIRALAX 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. |
| Participants aged 12 months to <2 years: CLENPIQ | Experimental | Drug: CLENPIQCLENPIQ 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. |
| Participants aged 12 months to <2 years: MIRALAX+SENNA | Active comparator | Drug: MIRALAX, Drug: SENNAMIRALAX 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. |
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLENPIQCLENPIQ 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. | Drug | Participants aged 12 months to <2 years: CLENPIQ, Participants aged 2 to <4 years: CLENPIQ, Participants aged 4 to <9 years: CLENPIQ |
| MIRALAXMIRALAX 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. | Drug | 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 |
| SENNASENNA 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. | Drug | 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 |
Primary outcome
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)
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.
15 secondary outcomes
Percentage of participants classified as "excellent" in the Modified Aronchick scale
Time frame: 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
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel fullness in your/the child's tummy since you/the child started the cleanout?
Time frame: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child wake up last night?
Time frame: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How often did you/the child feel sick to your/the child's stomach (nausea) since you/the child started the cleanout?
Time frame: On the day of colonoscopy (Day 1)
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How much were you/the child bothered by going to the bathroom since you/the child started the cleanout?
Time frame: On the day of colonoscopy (Day 1)
Systemic concentrations of picosulfate and bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM, active metabolite of picosulfate)
Time frame: 3 to 6 hours after the second dose of CLENPIQ prior to colonoscopy (Day 1).
Systemic concentrations of magnesium at screening
Time frame: Screening (≤21 days before scheduled colonoscopy)
Systemic concentrations of magnesium after randomization
Time frame: 3 to 6 hours after second dose of CLENPIQ prior to colonoscopy (Day 1); 1 or 2 days after the colonoscopy (Day 2 or 3)
Percentage of participants with adverse events (AEs)
Time frame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Percentage of participants with abnormal findings in vital signs
Time frame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Percentage of participants with abnormal findings in clinical laboratory tests
Time frame: From screening (≤21 days before scheduled colonoscopy) up to Day 28±7 after colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Bowel Preparation
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferring Pharmaceuticals A/S study director
Ferring Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CLENPIQ, MIRALAX and SENNA in people with Bowel Preparation, run by Ferring Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ferring Pharmaceuticals (+1 833-548-1402 (US/Canada), Disclosure@ferring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.