Bowel Preparation for Colonoscopy in Children

NCT01140295 | Terminated Phase 4 Results

• 1 other identifier: 2006-10-5004
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy Preparation

Keywords

Preparation; Pediatric; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

1, Miralax

ACTIVE COMPARATOR

Miralax colonoscopy preparation

Drug: polyethylene glycol, senna

2, senna

ACTIVE COMPARATOR

Senna colonoscopy preparation

Drug: polyethylene glycol, senna

Interventions

polyethylene glycol, senna DRUG

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

1, Miralax; 2, senna

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 22699838 DERIVED

MeSH Terms

Interventions

Polyethylene Glycols; Sennosides; polyethylene glycol 3350

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Limitations and Caveats

Early termination due to poor efficacy in one of the study arms (senna preparation).

Results Point of Contact

• Title: Petar Mamula
• Organization: The Children's Hospital of Philadelphia

mamula@email.chop.edu

215-590-9146

Study Officials

• Petar Mamula, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Endoscopy

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 9, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 12, 2013
• Results First Posted: April 12, 2013

Record last verified: 2013-04

Locations

US (1)