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Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation

NCT ID: NCT01398020

Last Updated: 2013-09-19

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

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-09-30

Brief Summary

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The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.

Detailed Description

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Conditions

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Efficacy of Bowel Preparation Ease of Bowel Preparation and Patient Tolerability

Keywords

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Bowel Preparation Patient comfort Bi-Peglyte

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard bowel prep

Subject will receive standard bowel prep prior to colonoscopy.

Group Type ACTIVE_COMPARATOR

Standard Bowel Prep

Intervention Type DRUG

Subjects will be asked to take 4L of Peglyte the day prior to procedure.

2L Bi-Peglyte

Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.

Group Type EXPERIMENTAL

2L Bi-Peglyte Bowel Prep

Intervention Type DRUG

Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

Interventions

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Standard Bowel Prep

Subjects will be asked to take 4L of Peglyte the day prior to procedure.

Intervention Type DRUG

2L Bi-Peglyte Bowel Prep

Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19 or older
* Outpatient colonoscopy

Exclusion Criteria

* constipation
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert A Enns, MD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H11-00688

Identifier Type: -

Identifier Source: org_study_id