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A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population

NCT00425594 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-12-27

No results posted yet for this study

Summary

This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.

Conditions

  • Colonoscopy

Interventions

DRUG

HalfLytely and Bisacodyl Tablets - Formulation 1

DRUG

HalfLytely and Bisacodyl Tablets - Formulation 2

DRUG

NuLYTELY

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • John McGowan · Braintree Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425594 on ClinicalTrials.gov