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

• ClinicalTrials.gov Identifier: NCT00953017
• Recruitment Status: Completed
• First Posted: August 6, 2009
• Results First Posted: November 30, 2012
• Last Update Posted: November 30, 2012
• Sponsor: Brooke Army Medical Center
• Information provided by (Responsible Party): Joel Z. Stengel, Brooke Army Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colonoscopy	Drug: Miralax (PEG 3350); Drug: Amitiza (Lubiprostone); Drug: Dulcolax (Bisacodyl); Drug: Golytely (polyethylene glycol)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 425 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The Cleanliness of the Prep as Measured by the Ottawa Scale [ Time Frame: measured at the time of colonoscopy ]
   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.

Secondary Outcome Measures :

1. Patient Satisfaction With the Prep Measured by 5 Point Likert Scale [ Time Frame: measured at check in to colonoscopy ]
   patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)
2. Procedure Time [ Time Frame: measured at the time of colonoscopy ]
   total colonoscopy procedure time
3. Polyps Detected [ Time Frame: measured at the time of colonoscopy ]
   Number of polyps

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Texas

Brooke Army Medical Center

San Antonio, Texas, United States, 78248

Sponsors and Collaborators

Brooke Army Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Joel Z. Stengel, Gastroenterology Fellow, Brooke Army Medical Center
• ClinicalTrials.gov Identifier: NCT00953017
• Other Study ID Numbers: C.2009.209
• First Posted: August 6, 2009
• Results First Posted: November 30, 2012
• Last Update Posted: November 30, 2012
• Last Verified: November 2012

Keywords provided by Joel Z. Stengel, Brooke Army Medical Center:

Efficacy of bowel cleansing; Patient tolerability; Amitiza; Dulcolax; Miralax; Colonoscopy preparation; Bowel preparation; Screening colonoscopy

Additional relevant MeSH terms:

Bisacodyl; Polyethylene glycol 3350; Lubiprostone; Cathartics; Gastrointestinal Agents; Laxatives; Chloride Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action