HalfLytely Bowel Prep System for Colonoscopy

NCT ID: NCT00164164

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Brief Summary

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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

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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HalfLytely

Intervention Type DRUG

NuLytely

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Braintree Laboratories

INDUSTRY

Sponsor Role lead

Principal Investigators

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Charles Brady, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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Braintree, Massachusetts, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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F38-20

Identifier Type: -

Identifier Source: org_study_id

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