Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-31 @ 5:53 AM
Study NCT ID:
NCT01140295
Status:
TERMINATED
Last Update Posted:
2013-04-12
First Post:
2010-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bowel Preparation for Colonoscopy in Children
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Polyethylene Glycol Powder Solution vs Senna for Bowel Preparation for Colonoscopy in Children: A Prospective, Randomized, Investigator-Blinded Trial.
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: