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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Amitiza (Lubiprostone); Drug: Dulcolax (Bisacodyl); Drug: Miralax (PEG 3350); Drug: Golytely (polyethylene glycol)

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78248
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Miralax plus Amitiza; 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Drug: Amitiza (Lubiprostone); Amitiza 24mcg gelcap
Active Comparator: Miralax plus Dulcolax; 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Drug: Dulcolax (Bisacodyl); Bisacodyl 5mg tab x2
Active Comparator: Miralax; 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Drug: Miralax (PEG 3350); Miralax 255gm bottle
Active Comparator: Golytely (polyethylene glycol); 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy	Drug: Golytely (polyethylene glycol); Golytely 1 gallon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Procedure Time	total colonoscopy procedure time	measured at the time of colonoscopy
Polyps Detected	Number of polyps	measured at the time of colonoscopy

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center

Publications and helpful links

General Publications

• Hjelkrem M, Stengel J, Liu M, Jones DP, Harrison SA. MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Clin Gastroenterol Hepatol. 2011 Apr;9(4):326-332.e1. doi: 10.1016/j.cgh.2010.11.007. Epub 2010 Nov 27.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 1, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Amitiza; Screening colonoscopy; Bowel preparation; Efficacy of bowel cleansing; Patient tolerability; Dulcolax; Miralax; Colonoscopy preparation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Membrane Transport Modulators; Cathartics; Chloride Channel Agonists; Laxatives; Bisacodyl; Lubiprostone; Polyethylene glycol 3350
• Other Study ID Numbers: C.2009.209