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Bowel Preparation with CLENPIQ vs. MIRALAX for Colon Cleansing (PICCOLO Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have had an average of three or more spontaneous bowel movements (SBM) per week for 1 month prior to the colonoscopy
Male or female, aged 2 years to <9 years being scheduled to undergo elective colonoscopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy
Awards & highlights
PICCOLO Trial Summary
This trial compares two bowel preparation regimens for colonoscopy in children.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of both CLENPIQ and MIRALAX may include nausea, vomiting, abdominal pain, dehydration, and electrolyte disturbances. These products are used to empty the bowels so they might also cause discomfort like bloating or cramping.
PICCOLO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had 3 or more bowel movements per week for the last month.
Select...
I am between 2 and 8 years old and scheduled for a colonoscopy.
Select...
I weigh at least 22 pounds.
PICCOLO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (≤21 days before scheduled colonoscopy) up to day 28±7 after colonoscopy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants classified as responders, defined by "excellent" or "good" in the Modified Aronchick scale
Secondary outcome measures
Frequency of each category of the Modified Tolerability and Satisfaction Questionnaire: How did the bowel cleanout medicine taste?
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?
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?
+12 moreSide effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605126%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350
PICCOLO Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Participants aged 4 to <9 years: CLENPIQExperimental Treatment1 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: CLENPIQExperimental Treatment1 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 4 to <9 years: MIRALAXActive Control1 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.
Group IV: Participants aged 2 to <4 years: MIRALAXActive Control1 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.
Find a Location
Who is running the clinical trial?
Ferring PharmaceuticalsLead Sponsor
314 Previous Clinical Trials
440,853 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
63 Previous Clinical Trials
357,390 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 3 or more bowel movements per week for the last month.I have had significant stomach pain recently.I am between 2 and 8 years old and scheduled for a colonoscopy.I have severe IBD symptoms right now.I have a history of serious stomach or intestine problems.I have not taken lithium, laxatives, constipation-causing drugs, antidiarrheals, or oral iron within the specified times before the procedure.I have had neurological issues, possibly related to low sodium, recently.I weigh at least 22 pounds.You have had significant dehydration recently.You have previously experienced epileptic reactions, convulsions, or seizures.I have no major liver, heart, or kidney diseases.I have had surgery on my upper stomach area, but not for gallbladder removal.I have a history of specific colon diseases.I have had or currently have severe intestinal problems.I have not taken part in a drug trial within the last 30 days.I have had severe nausea or vomiting for a while now.I have had surgery for colorectal issues, but not for appendicitis or polyp removal.I do not have any urgent stomach surgery needs like blockages or holes.You are allergic to any of the ingredients in the trial medications.
Research Study Groups:
This trial has the following groups:- Group 1: Participants aged 4 to <9 years: MIRALAX
- Group 2: Participants aged 2 to <4 years: MIRALAX
- Group 3: Participants aged 2 to <4 years: CLENPIQ
- Group 4: Participants aged 4 to <9 years: CLENPIQ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for me to contribute to this clinical research?
"This clinical trial is looking to enrol approximately 30 participants, aged 2-8 years old. Additionally, individuals must have had prior bowel preparation therapy in order to qualify for the study."
Answered by AI
Is recruitment for the trial still occurring?
"Affirmative. Clinicaltrials.gov has verified that this trial, which originally opened on June 23rd 2022 is presently open for recruitment. The study requires 30 participants from 6 different sites to participate in the research."
Answered by AI
How many subjects are currently enrolled in the experiment?
"This research requires 30 eligible participants to take part, who can be recruited from various medical centres such as GI for Kids in Knoxville or The Children's Hospital at Montefiore in Bronx."
Answered by AI
Has CLENPIQ been put through its paces in additional medical experiments?
"CLENPIQ was initially trialled in 2012 at Genesys Regional Medical Center. At present, there are 184 concluded trials and 24 on-going ones happening primarily around Knoxville and New york City."
Answered by AI
Does eligibility for this trial extend to individuals aged 80 and below?
"The inclusion criteria of this medical trial necessitates that participants are aged between two and eight years old. Also, there is a separate study for those 18 or younger as well as one specifically designed for seniors over 65."
Answered by AI
What medical conditions is CLENPIQ used to treat?
"CLENPIQ is a commonly prescribed medication to reduce hunger, but it also has other applications such as aiding colonoscopy preparation and alleviating dry eyes and blood specimen collection."
Answered by AI
How widespread is the clinical trial across North America?
"GI for Kids in Knoxville, New york; The Children's Hospital at Montefiore in Bronx, Washington; and MultiCare Institute for Research & Innovation in Tacoma, California are just a few of the 6 locations that this research is taking place."
Answered by AI
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