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A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment for Bowel Cleansing Prior to Colonoscopy

Information source: Brooke Army Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colonoscopy

Intervention: Miralax (PEG 3350) (Drug); Amitiza (Lubiprostone) (Drug); Dulcolax (Bisacodyl) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Brooke Army Medical Center

Overall contact:
Joel Z Stengel, MD, Phone: 210-916-3647, Email: joel.stengel@us.army.mil

Summary

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Clinical Details

Official title: A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment for Bowel Cleansing Prior to Colonoscopy

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Primary outcome: The cleanliness of the prep as measured by the Ottawa Scale

Secondary outcome:

Patient satisfaction with the prep measured by 5 point Likert scale

Procedure time

The number and size of polyps detected on examination

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients referred to our clinic for average or increased risk screening for

colorectal cancer

Exclusion Criteria:

- elevated serum creatinine (Men >1. 4mg/dL, Women >1. 3mg/dL)

- previous diagnosis of congestive heart failure

- history of bowel obstruction

- history of solid organ transplant

- current pregnancy

- lactating mother

- participants allergic to either polyethylene glycol (Miralax), lubiprostone

(Amitiza), or bisacodyl (Dulcolax)

Locations and Contacts

Joel Z Stengel, MD, Phone: 210-916-3647, Email: joel.stengel@us.army.mil

Brooke Army Medical Center, San Antonio, Texas 78248, United States; Recruiting
Joel Z Stengel, MD, Principal Investigator
Additional Information

Starting date: July 2009
Last updated: August 5, 2009

Page last updated: October 04, 2010

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