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A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely

NCT ID: NCT00889655

Last Updated: 2009-04-29

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.

Detailed Description

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Conditions

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Colonoscopy

Keywords

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efficacy of bowel cleansing patient tolerability Golytely MiraLax colonoscopy preparation bowel preparation screening colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Golytely

216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy

Group Type ACTIVE_COMPARATOR

Golytely (polyethylene glycol)

Intervention Type DRUG

4 L of golytely, in split dosing. If the patient has a morning colonoscopy, they will take 2 L of golytely over 2 hours the morning prior to their procedure and repeat this at 6 pm the night prior to their procedure.

MiraLax

216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser

Group Type EXPERIMENTAL

MiraLax (polyethylene glycol 3350)

Intervention Type DRUG

238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.

Interventions

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Golytely (polyethylene glycol)

4 L of golytely, in split dosing. If the patient has a morning colonoscopy, they will take 2 L of golytely over 2 hours the morning prior to their procedure and repeat this at 6 pm the night prior to their procedure.

Intervention Type DRUG

MiraLax (polyethylene glycol 3350)

238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* average risk screening for colon cancer

Exclusion Criteria

* subjects with a history of constipation
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Oregon Health & Science University, Division of Gastroenterology

Locations

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Oregon Health & Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Glenn Eisen, MD, MPH

Role: CONTACT

Phone: 503-494-8311

Email: [email protected]

Brintha K Enestvedt, MD, MBA

Role: CONTACT

Phone: 503-494-8311

Email: [email protected]

References

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Enestvedt BK, Fennerty MB, Eisen GM. Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2011 Jan;33(1):33-40. doi: 10.1111/j.1365-2036.2010.04493.x. Epub 2010 Oct 25.

Reference Type DERIVED
PMID: 21083586 (View on PubMed)

Other Identifiers

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IRB00005072

Identifier Type: -

Identifier Source: org_study_id