HalfLytely Bowel Prep System for Colonoscopy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00164164

Enrollment

200

Registered

2005-09-14

Start date

1999-08-31

Completion date

Unknown

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

colonoscopy preparation, prep

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.

Interventions

DRUGHalfLytely

DRUGNuLytely

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Efficacy - Bowel preparation success: preparation rated as good or excellent by the blinded examiner	—

Secondary

Measure	Time frame
Safety - Review of preparation symptoms, adverse events, and laboratory testing	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026