NCT00164164

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

September 9, 2005

Last Update Submit

February 6, 2013

Conditions

Colonoscopy

Keywords

colonoscopy preparationprep

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Safety - Review of preparation symptoms, adverse events, and laboratory testing

Interventions

HalfLytelyDRUG
NuLytelyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Braintree, Massachusetts, 02184, United States

Location

Unknown Facility

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Interventions

polyethylene glycol 3350

Study Officials

  • Charles Brady, MD

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

August 1, 1999

Primary Completion

June 1, 2000

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(2)