HalfLytely Bowel Prep System for Colonoscopy | NCT00164164

Studies
HalfLytely Bowel Prep System for Colonoscopy

NCT00164164

Sponsor

Braintree Laboratories

Status

Completed

Last Update Posted

Feb 7, 2013Estimated

Enrollment

200

Phase

Phase 3

Conditions

Colonoscopy

Interventions

HalfLytely
NuLytely

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 1999

Primary Completion Date

Jun 2000Actual

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2013

Last Update Posted Date

Feb 7, 2013Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy - Bowel preparation success: preparation rated as "good" or "excellent" by the blinded examiner

Secondary Outcomes

Measure	Description	Time Frame
Safety - Review of preparation symptoms, adverse events, and laboratory testing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Brady, MD	The University of Texas Health Science Center at San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Braintree	Massachusetts	02184	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000595212	polyethylene glycol 3350

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
HalfLytely	Drug
NuLytely	Drug