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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953017
• Other study ID #: C.2009.209
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: November 1, 2012
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2012
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Miralax (PEG 3350)
Miralax 255gm bottle
• Amitiza (Lubiprostone)
Amitiza 24mcg gelcap
• Dulcolax (Bisacodyl)
Bisacodyl 5mg tab x2
• Golytely (polyethylene glycol)
Golytely 1 gallon

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Cleanliness of the Prep as Measured by the Ottawa Scale	Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.	measured at the time of colonoscopy	No
Secondary	Patient Satisfaction With the Prep Measured by 5 Point Likert Scale	patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)	measured at check in to colonoscopy	Yes
Secondary	Procedure Time	total colonoscopy procedure time	measured at the time of colonoscopy	No
Secondary	Polyps Detected	Number of polyps	measured at the time of colonoscopy	No