HalfLytely Bowel Prep System for Colonoscopy

Phase 3

Completed

• Conditions: Colonoscopy

• Registration Number: NCT00164164
• Lead Sponsor: Braintree Laboratories

Brief Summary

The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-08
• Primary Completion: 2000-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male or female outpatients at least 18 years of age
• All women of childbearing potential (this includes women who are single and women whose sexual partners have been vasectomized) are required to use medically acceptable contraception during their participation in the study.
• In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
• Patient is undergoing a colonoscopy for a routinely accepted indication

Exclusion Criteria

• ileus
• possible intestinal obstruction or perforation
• prior alimentary tract surgery
• significant gastroparesis or gastric outlet obstruction
• impaired consciousness that predisposes a patient to pulmonary aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner

Secondary Outcome Measures

Name	Time	Method
Safety - Review of preparation symptoms, adverse events, and laboratory testing