Trial Outcomes & Findings for Bowel Preparation for Colonoscopy in Children (NCT NCT01140295)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

The outcome measure will be assessed once one day after the completion of colonoscopy preparation

Results posted on

2013-04-12

Participant Flow

Patients were recruited at The Children's Hospital of Philadelphia Main site Endoscopy suite from September 2010 to April 2011.

365 patients were screened. 98 were eligible according to inclusion/exclusion criteria. 41 declined participation. criteria. Of the 57 eligible patients 33 were enrolled when the study was prematurely terminated.

Participant milestones

Participant milestones
Measure	1, Miralax Miralax colonoscopy preparation Miralax (PEG-P) 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.	2, Senna Senna colonoscopy preparation 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.
Overall Study STARTED	17	16
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bowel Preparation for Colonoscopy in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1, Miralax n=17 Participants Miralax colonoscopy preparation 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.	2, Senna n=16 Participants Senna colonoscopy preparation 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.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12 years STANDARD_DEVIATION 1.3 • n=5 Participants	15 years STANDARD_DEVIATION 1.2 • n=7 Participants	14.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1, Miralax n=17 Participants Miralax colonoscopy preparation 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.	2, Senna n=16 Participants Senna colonoscopy preparation 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.
Efficacy of Colon Preparation	88 percentage of patients	28 percentage of patients

SECONDARY outcome

Timeframe: The outcome measure will be assessed once one day after the completion of colonoscopy preparation

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.

Outcome measures

Outcome measures
Measure	1, Miralax n=17 Participants Miralax colonoscopy preparation 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.	2, Senna n=16 Participants Senna colonoscopy preparation 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.
Proportion of Patients With Abnormal Electrolyte Levels	0 Proportion of patients	0 Proportion of patients

Adverse Events

1, Miralax

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2, Senna

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Petar Mamula

The Children's Hospital of Philadelphia

Phone: 215-590-9146

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place