ColonoscopyPhase 4NCT01711437
Different Bowel Preparations for Colonoscopy In Children
A Phase 4 study testing PEG-4000 with citrates and simethicone, polyethylene glycol 4000 solution with simethicon and polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid in people with Colonoscopy, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN. THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- PEG-4000 with citrates and simethicone, polyethylene glycol 4000 solution with simethicon and polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study.
Who cannot join
- requirement for urgent colonoscopy,
- bowel obstruction,
- known or suspected hypersensitivity to the active or other ingredients,
- clinically significant electrolyte imbalance,
- prior intestinal resection,
- known metabolic, renal and cardiac disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"
Roma, 00161
Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza", 0649979326, giovanni.dinardo@uniroma1.it
About this study
Official title: EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN
THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN.
THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING
Read the detailed description
COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE: INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.
THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON CLEANOUT.
PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF THIS METHODS.
- Conditions
- Colonoscopy
- Being tested
- PEG-4000 with citrates and simethicone, polyethylene glycol 4000 solution with simethicon, polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid, sodium picosulphate plus magnesium oxide and citric acid
- Keywords
- colonoscopy, colon cleansing, children, age 2 -18 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-4000 with citrates and simethiconeDevice
Also called lovol-esse
1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours.
polyethylene glycol 4000 solution with simethiconDevice
Also called selg-esse
patients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
polyethylene glycol 3350 hyper-osmotic solution with ascorbic acidDevice
Also called moviprep
patients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake.
sodium picosulphate plus magnesium oxide and citric acidDevice
Also called Picoprep
patients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids
| Study group | Role | What they receive |
|---|---|---|
| PEG-S | Experimental | polyethylene glycol 4000 solution with simethicon Receives: Device: polyethylene glycol 4000 solution with simethicon |
| PEG-CS + Bisacodyl | Experimental | PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone Receives: Device: PEG-4000 with citrates and simethicone |
| PEG-ASC | Experimental | polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid Receives: Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid |
| picoprep | Experimental | sodium picosulphate plus magnesium oxide and citric acid Receives: Device: sodium picosulphate plus magnesium oxide and citric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system.
The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3).
Measured: During the performance of colonoscopy
Secondary outcomes (4)
safety
Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.
Measured: 4 days
clinical tolerabiity
Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Measured: On the morning of colonoscopy, immediately before the procedure
Compliance
Compliance was scored on a 3-point scale according to the percentage of drunk solution
Measured: On the morning of colonoscopy, immediately before the procedure
Acceptability
The easiness of taking or swallowing the solution was graded according to the following scale: very severe distress = 4, severe distress = 3, moderate distress = 2, mild distress = 1, no distress = 0.
Measured: On the morning of colonoscopy, immediately before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711437
- Sponsor's protocol ID
- PEG-P2
- Status last verified
- Oct 2012
- First submitted
- 18 Oct 2012
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN
- ClinicalTrials.gov ID
- NCT01711437
- Acronym / sponsor ID
- PEG-P2
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, colon cleansing, children, age 2 -18 years
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 22 Oct 2012 (estimated)
- 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.
THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN.
THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING
Detailed description
COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE: INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.
THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON CLEANOUT.
PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF THIS METHODS.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEG-S | Experimental | Device: polyethylene glycol 4000 solution with simethiconpolyethylene glycol 4000 solution with simethicon |
| PEG-CS + Bisacodyl | Experimental | Device: PEG-4000 with citrates and simethiconePEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone |
| PEG-ASC | Experimental | Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acidpolyethylene glycol 3350 hyper-osmotic solution with ascorbic acid |
| picoprep | Experimental | Device: sodium picosulphate plus magnesium oxide and citric acidsodium picosulphate plus magnesium oxide and citric acid |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study.
Key exclusion criteria (6 listed)
- requirement for urgent colonoscopy,
- bowel obstruction,
- known or suspected hypersensitivity to the active or other ingredients,
- clinically significant electrolyte imbalance,
- prior intestinal resection,
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 |
|---|---|---|
| PEG-4000 with citrates and simethiconeAlso: lovol-esse1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours. | Device | PEG-CS + Bisacodyl |
| polyethylene glycol 4000 solution with simethiconAlso: selg-essepatients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours. | Device | PEG-S |
| polyethylene glycol 3350 hyper-osmotic solution with ascorbic acidAlso: movipreppatients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake. | Device | PEG-ASC |
| sodium picosulphate plus magnesium oxide and citric acidAlso: Picopreppatients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids | Device | picoprep |
Primary outcome
Efficacy
Time frame: During the performance of colonoscopy
Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system. The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3).
4 secondary outcomes
safety
Time frame: 4 days
clinical tolerabiity
Time frame: On the morning of colonoscopy, immediately before the procedure
Compliance
Time frame: On the morning of colonoscopy, immediately before the procedure
Acceptability
Time frame: On the morning of colonoscopy, immediately before the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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. This study is not recruiting at the moment.
Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-4000 with citrates and simethicone, polyethylene glycol 4000 solution with simethicon and polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid in people with Colonoscopy, run by Azienda Policlinico Umberto I at 1 site in Italy.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: During the performance of colonoscopy). 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 6 Nov 2012.