Colonoscopy PreparationPhase 4NCT01140295
Bowel Preparation for Colonoscopy in Children
A Phase 4 study testing polyethylene glycol, senna in people with Colonoscopy Preparation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Colonoscopy Preparation
- What is being tested?
- polyethylene glycol, senna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects age 6-21 yrs for senna, PEG-P groups
- Subjects age 13-21 yrs for NaP group
- First time colonoscopy
- Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)
Who cannot join
- Chronic renal, liver, or heart failure
- Chronic constipation
- Patients on the GI inpatient or consult service.
- Subjects taking senna or PEG on a regular basis for laxative reasons.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Polyethylene Glycol Powder Solution vs Senna for Bowel Preparation for Colonoscopy in Children: A Prospective, Randomized, Investigator-Blinded Trial.
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
Read the detailed description
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).
- Conditions
- Colonoscopy Preparation
- Being tested
- polyethylene glycol, senna
- Keywords
- Preparation, Pediatric, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol, sennaDrug
Also called Miralax, Senna
Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.
| Study group | Role | What they receive |
|---|---|---|
| 1, Miralax | Active comparator | Miralax colonoscopy preparation Receives: Drug: polyethylene glycol, senna |
| 2, senna | Active comparator | Senna colonoscopy preparation Receives: Drug: polyethylene glycol, senna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Colon Preparation
Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.
Measured: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Secondary outcomes (1)
Proportion of Patients With Abnormal Electrolyte Levels
The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.
Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant.
Measured: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PreparationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petar Mamula, Children's Hospital of Philadelphia
- Investigators
- Petar Mamula, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140295
- Sponsor's protocol ID
- 2006-10-5004
- Status last verified
- Apr 2013
- First submitted
- 1 Jun 2010
- Last updated
- 12 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Terry NA, Chen-Lim ML, Ely E, Jatla M, Ciavardone D, Esch S, Farace L, Jannelli F, Puma A, Carlow D, Mamula P. Polyethylene glycol powder solution versus senna for bowel preparation for colonoscopy in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):215-9. doi: 10.1097/MPG.0b013e3182633d0a.
PubMed 22699838
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Glycol Powder Solution vs Senna for Bowel Preparation for Colonoscopy in Children: A Prospective, Randomized, Investigator-Blinded Trial.
- ClinicalTrials.gov ID
- NCT01140295
- Acronym / sponsor ID
- 2006-10-5004
- Conditions
- Colonoscopy Preparation
- Keywords
- Preparation, Pediatric, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 12 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
Detailed description
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, Miralax | Active comparator | Drug: polyethylene glycol, sennaMiralax colonoscopy preparation |
| 2, senna | Active comparator | Drug: polyethylene glycol, sennaSenna colonoscopy preparation |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects age 6-21 yrs for senna, PEG-P groups
- Subjects age 13-21 yrs for NaP group
- First time colonoscopy
- Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)
Key exclusion criteria (5 listed)
- Chronic renal, liver, or heart failure
- Chronic constipation
- Patients on the GI inpatient or consult service.
- Subjects taking senna or PEG on a regular basis for laxative reasons.
- Pregnant or lactating females
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 |
|---|---|---|
| polyethylene glycol, sennaAlso: Miralax, SennaSenna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure. Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days. | Drug | 1, Miralax, 2, senna |
Primary outcome
Efficacy of Colon Preparation
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.
1 secondary outcome
Proportion of Patients With Abnormal Electrolyte Levels
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22699838Terry NA, Chen-Lim ML, Ely E, Jatla M, Ciavardone D, Esch S, Farace L, Jannelli F, Puma A, Carlow D, Mamula P. Polyethylene glycol powder solution versus senna for bowel preparation for colonoscopy in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):215-9. doi: 10.1097/MPG.0b013e3182633d0a.
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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.
Petar Mamula, MD principal investigator
Children's Hospital of Philadelphia
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 polyethylene glycol, senna in people with Colonoscopy Preparation, run by Children's Hospital of Philadelphia at 1 site 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 5 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: stopped early, as of the sponsor's last update on 12 Apr 2013. 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 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 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?
Yes. Results are posted in the registry (first posted 12 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Colon Preparation (time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140295, which also lists 1 linked publication.
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 12 Apr 2013.