A Phase 4 interventional study of polyethylene glycol, senna in Colonoscopy Preparation, sponsored by Children's Hospital of Philadelphia. Terminated at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2013-04-12.
Sponsored by Children's Hospital of Philadelphia · Phase 4 and Interventional
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
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).
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Miralax colonoscopy preparation
Drug: polyethylene glycol, senna
Senna colonoscopy preparation
Drug: polyethylene glycol, 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.
Also known as: Miralax, Senna
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.
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
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.
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
Patients were recruited at The Children's Hospital of Philadelphia Main site Endoscopy suite from September 2010 to April 2011.
| Milestone | 1, Miralax | 2, Senna |
|---|---|---|
| Started | 17 | 16 |
| Completed | 16 | 14 |
| Not completed | 1 | 2 |
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.
| percentage of patients | 1, Miralax | 2, Senna |
|---|---|---|
| Efficacy of Colon Preparation | 88 | 28 |
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.
| Proportion of patients | 1, Miralax | 2, Senna |
|---|---|---|
| Proportion of Patients With Abnormal Electrolyte Levels | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1, Miralax | — | 0/17 (0%) | 0/17 (0%) |
| 2, Senna | — | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | 1, Miralax | 2, Senna | Total |
|---|---|---|---|
| <=18 years | 17 | 16 | 33 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | 1, Miralax | 2, Senna | Total |
|---|---|---|---|
| Mean | 12 ± 1.3 | 15 ± 1.2 | 14.5 ± 5 |
| Sex: Female, Male(Participants) | 1, Miralax | 2, Senna | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 11 | 8 | 19 |
| Region of Enrollment(participants) | 1, Miralax | 2, Senna | Total |
|---|---|---|---|
| United States | 17 | 16 | 33 |
This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia