Bowel Preparation with CLENPIQ vs. MIRALAX for Colon Cleansing

(PICCOLO Trial)

Recruiting at 11 trial locations

Overseen By Global Clinical Compliance

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ferring Pharmaceuticals

Must not be taking: Lithium, Laxatives, Antidiarrheals, others

Disqualifiers: Liver disease, Cardiovascular, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different bowel preparation treatments, CLENPIQ (a combination of sodium picosulfate, magnesium oxide, and anhydrous citric acid) and MIRALAX (polyethylene glycol 3350), to determine the best option for children needing a colonoscopy. The goal is to identify which treatment cleans the colon most effectively. Children aged 2 to 9 with regular bowel movements and scheduled for a colonoscopy might be suitable candidates. This research aims to help doctors choose the safest and most effective preparation method for young patients undergoing this important procedure. As a Phase 1, Phase 2 trial, the study focuses on understanding how the treatments work and measuring their effectiveness in a smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before the procedure: lithium (48 hours prior), laxatives (24 hours prior), drugs causing constipation (48 hours prior), antidiarrheal drugs (72 hours prior), and oral iron preparations (1 week prior).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CLENPIQ, used for colon cleansing, is generally well-tolerated by adults. Common side effects include nausea, headaches, and stomach pain. Some individuals have experienced dehydration and changes in blood salt levels, which are important to monitor, especially in children.

For MIRALAX, studies indicate it is safe for children when used in a one-day, weight-based plan. Changes in electrolyte levels and kidney function were not significant. It is widely used for treating constipation and is approved by the FDA for this purpose, suggesting it is generally safe.

Both treatments are usually well-tolerated, but it is important to stay hydrated and follow the dosing instructions carefully. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments CLENPIQ and MIRALAX for colon cleansing because they offer different approaches for bowel preparation in young children. Unlike other treatments that typically require larger volumes of liquid intake, CLENPIQ uses a "split-dose" method, which involves consuming smaller, more manageable amounts at two different times, making it potentially easier for children to tolerate. MIRALAX, on the other hand, is mixed with a clear, non-carbonated beverage, which can be more palatable for kids. Both treatments aim to improve the experience and effectiveness of bowel preparation, which is crucial for successful colonoscopy procedures.

What evidence suggests that this trial's treatments could be effective for bowel preparation in pediatric colonoscopy?

This trial will compare the effectiveness of CLENPIQ and MIRALAX for colon cleansing in preparation for colonoscopy. Studies have shown that CLENPIQ, which contains sodium picosulfate, magnesium oxide, and anhydrous citric acid, effectively cleans the colon. It allows doctors to view over 90% of the colon's surface with mostly liquid stool, ensuring good preparation for colonoscopies. Additionally, 99% of patients complete most of the CLENPIQ preparation, and 90% find it tolerable.

Research indicates that MIRALAX cleans the bowel effectively, similar to other solutions. About 94% of patients achieve successful colon cleansing. Known for its ease of use and pleasant taste, it remains a popular choice for bowel preparation. Both treatments in this trial have shown promising results in effectively preparing patients for colonoscopy procedures. ^{1 6 7 8 9}

Who Is on the Research Team?

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 2 to <9 years, weighing at least 10 kg, who are scheduled for a colonoscopy and have regular bowel movements. They must not have certain gastrointestinal disorders or electrolyte imbalances, nor should they be on medications that affect bowel movements or have had recent surgeries affecting the gut.

Inclusion Criteria

I have had 3 or more bowel movements per week for the last month.

I am between 2 and 8 years old and scheduled for a colonoscopy.

I weigh at least 22 pounds.

Exclusion Criteria

I have had significant stomach pain recently.

I have severe IBD symptoms right now.

I have a history of serious stomach or intestine problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive bowel preparation with either MIRALAX or CLENPIQ prior to colonoscopy

1 day

1 visit (in-person) for colonoscopy

Follow-up

Participants are monitored for safety and effectiveness after colonoscopy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLENPIQ
• MIRALAX

Trial Overview The study is testing CLENPIQ versus MIRALAX as methods to clean out the bowels before a child undergoes a colonoscopy. The goal is to determine which one works better in preparing children's colons for clear viewing during the procedure.

How Is the Trial Designed?

Group I: Participants aged 4 to <9 years: CLENPIQ Experimental Treatment 1 Intervention

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.

Group II: Participants aged 2 to <4 years: CLENPIQ Experimental Treatment 1 Intervention

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.

Group III: Participants aged 2 to <4 years: MIRALAX Active Control 1 Intervention

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.

Group IV: Participants aged 4 to <9 years: MIRALAX Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Published Research Related to This Trial

In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating chronic constipation over a 12-month period, with 80-88% of patients reporting successful treatment outcomes.

The treatment was associated with mild to moderate gastrointestinal side effects, such as diarrhea and nausea, but there were no significant changes in blood chemistry or hematology, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

In a study involving guinea pigs sensitized to cow's milk, treatment with diosmectite for one week prevented digestive disturbances caused by beta-lactoglobulin, a milk protein.

Diosmectite treatment maintained normal colonic transit time and intestinal permeability, suggesting it may be an effective protective intervention against food allergies in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective action of diosmectite treatment on digestive disturbances induced by intestinal anaphylaxis in the guinea-pig. Theodorou, V., Fioramonti, J., Droy-Lefaix, MT., et al.[2019]

In a study of 150 patients undergoing colonoscopy, the split-dose PEG-AA regimen provided significantly better bowel preparation quality compared to the single-dose PEG-3350 combined with a sports drink and bisacodyl, as measured by the Boston Bowel Preparation Scale.

There was no difference in patient satisfaction or serum electrolyte changes between the two regimens, suggesting that PEG-3350 does not offer any benefits over PEG-AA for bowel preparation and should be reconsidered for this use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol-3350 (Miralax®)+1.9-L sports drink (Gatorade®)+2 tablets of bisacodyl results in inferior bowel preparation for colonoscopy compared with Polyethylene Glycol-Ascorbic Acid (MoviPrep®). Khan, MA., Patel, KB., Nooruddin, M., et al.[2020]

The study found that while the alkalinity of five different 38% silver diamine fluoride (SDF) solutions remained stable over 180 days, their fluoride and silver ion concentrations significantly decreased after 60 days, indicating a loss of efficacy over time.

It is recommended that these SDF solutions be used within 60 days of opening to ensure optimal therapeutic benefits, as substantial changes in fluoride and silver concentrations were observed beyond this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of Silver and Fluoride Contents in Silver Diamine Fluoride Solutions. Yan, IG., Zheng, FM., Yin, IX., et al.[2023]

In two clinical studies involving 33 subjects, a new dentifrice with 0.2% triclosan and 3.0% PVM/MA copolymer was found to be as effective as a positive control dentifrice in reducing dental plaque, as measured by the Modified Gingival Margin Plaque Index (MGMPI).

Both the new dentifrice and the positive control significantly outperformed a negative control dentifrice containing only sodium fluoride, indicating that the active ingredients in the tested dentifrices are effective in controlling plaque buildup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical investigation of the antiplaque efficacy of a new variant of a commercially available triclosan/copolymer/fluoride dentifrice. Barnes, VM., Richter, R., Vandeven, M., et al.[2016]

In a study of 190 patients undergoing screening colonoscopy, Golytely was found to be more effective for bowel cleansing than MiraLAX/Gatorade, with higher Boston Bowel Preparation Scale (BBPS) scores indicating better cleansing efficacy.

Despite the difference in efficacy, both bowel preparation methods were equally tolerated by patients, suggesting that while Golytely is more effective, MiraLAX/Gatorade may still be a viable option for those who prefer it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Enestvedt, BK., Fennerty, MB., Eisen, GM.[2018]

The 1.23% acidulated phosphate fluoride (APF) gel significantly etches the surface of light-cured glass ionomer cement, indicating a strong interaction that could affect the material's integrity.

Applying a protective surface glazing to the glass ionomer effectively shields it from the etching effects of the APF gel, while the neutral 1.1% sodium fluoride gel showed no significant impact on the glass ionomer surface.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fluoridated gels on a light-cured glass ionomer cement: an SEM study. Garcia-Godoy, F., Leon de Perez, S.[2013]

The new anti-hypersensitivity dentifrice has a low Relative Dentine Abrasivity (RDA) value of 34, indicating it is gentle on tooth surfaces while effectively treating dentinal hypersensitivity.

In in vitro tests, the dentifrice demonstrated superior stain removal compared to Sensodyne MultiCare and a conventional formulation, and performed similarly to Elmex Sensitive, suggesting it is effective for maintaining oral aesthetics without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The stain removal performance of a new anti-hypersensitivity dentifrice. Creeth, JE., Price, KS., Wicks, MA.[2006]

In a study of 350 Japanese patients, sodium picosulfate plus magnesium citrate achieved adequate bowel preparation in 84.3% of participants, indicating its overall effectiveness and high patient acceptability.

A scoring model was developed to predict inadequate bowel preparation based on five risk factors, achieving a C-statistic of 0.75, which helps identify patients at higher risk for inadequate preparation before colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Inadequate Bowel Preparation When Using Sodium Picosulfate plus Magnesium Citrate for Colonoscopy: Development and Validation of a Prediction Score. Okamoto, N., Tanaka, S., Abe, H., et al.[2022]

In a study involving 403 patients, the standard bowel preparation regimen GoLytely was found to be significantly more effective for bowel cleansing compared to MiraLAX alone or when combined with bisacodyl or lubiprostone, as measured by the Ottawa bowel preparation scale.

Despite being less effective, patients who used MiraLAX reported higher satisfaction with their preparation experience compared to those who used GoLytely, indicating a trade-off between efficacy and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Hjelkrem, M., Stengel, J., Liu, M., et al.[2018]

In a study of 233 patients, magnesium citrate plus sodium picosulfate achieved adequate bowel cleansing in 94.85% and excellent cleansing in 72.96%, demonstrating its high efficacy for colonoscopy preparation.

The treatment was well tolerated, with 47.21% of patients reporting no or very mild symptoms, and while there were significant changes in serum electrolyte levels, these were not clinically relevant, indicating safety in renal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate - a phase IV clinical observational study. Bor, R., Matuz, M., Fabián, A., et al.[2022]

In a study of 778 average-risk individuals aged 50 and older, the combination of MiraLAX, Gatorade, and bisacodyl resulted in a higher rate of excellent or good bowel cleansing (93.3%) compared to the traditional 4-liter GoLytely (89.3%), indicating its efficacy as a bowel preparation method.

No serious adverse events were reported, suggesting that the MiraLAX combination is a safe alternative for bowel cleansing prior to colonoscopy, especially in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiraLAX-Gatorade bowel prep versus GoLytely before screening colonoscopy: an endoscopic database study in a community hospital. Shieh, FK., Gunaratnam, N., Mohamud, SO., et al.[2022]

The review analyzed various bowel cleansing regimens before colonoscopy, including polyethylene glycol (PEG) solutions and oral sodium phosphate, to determine their effectiveness and safety.

The authors recommend four effective bowel cleansing methods, highlighting PEG-electrolyte solutions combined with senna as a top choice, due to their balance of cleansing effectiveness, safety, and patient tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bowel preparation before colonoscopy. Choosing the best lavage regimen. Tooson, JD., Gates, LK.[2022]

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf

CLENPIQ® (sodium picosulfate, magnesium oxide, and ... Successful colon cleansing was defined as bowel preparations with >90% of the mucosa seen and mostly liquid stool that were graded excellent (minimal suctioning.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03017235?term=000253&rank=1

A Study Comparing the Sodium Picosulfate, Magnesium ... A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous ...

3. ferringusa.com ferringusa.com/?press=ferring-to-present-clinical-data-on-efficacy-and-safety-of-clenpiqtm-sodium-picosulfate-magnesium-oxide-and-anhydrous-citric-acid-oral-solution-for-colonoscopy-prep-at-digestive-disease-week

Ferring to Present Clinical Data on Efficacy and Safety ... The study evaluated the efficacy of a split-dose regimen of sodium picosulfate, magnesium oxide, and anhydrous citric acid in a ready to drink oral solution.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4213938/

Effectiveness of Sodium Picosulfate/Magnesium Citrate ... Picolight (PICO) has an acceptable taste and patient tolerance because of the small volume required, and its bowel preparation efficacy is comparable to that of ...

5. clenpiqhcp.com clenpiqhcp.com/dosing/

Tolerability & Dosing - CLENPIQ 99% of patients completed the majority of the CLENPIQ prep. 98% are “mostly” or “somewhat willing” to take CLENPIQ again. 90% felt that the tolerability of ...

6. clenpiq.com clenpiq.com/

CLENPIQ CLENPIQ and other bowel preparations can cause serious side effects, including serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/sodium-picosulfate-magnesium-and-citric-acid-oral-route/description/drg-20075687

Sodium picosulfate, magnesium, and citric acid (oral route) Citric acid, magnesium oxide, and sodium picosulfate combination is used to cleanse the colon (bowel) in preparation for a procedure called colonoscopy.

8. clenpiqhcp.com clenpiqhcp.com/

CLENPIQ® – A Next-Generation Split-Dose Bowel Prep The most common adverse reactions reported in a clinical trial with CLENPIQ for colon cleansing in adults were nausea, headache, hypermagnesemia, abdominal pain ...

9. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b759dc12-2dc1-4ef4-a375-1a61630d54d6

sodium picosulfate, magnesium oxide and anhydrous citric ... Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution and other bowel preparations can cause serious side effects, including: Serious ...