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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: May 2010

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • Procedure Time
    • Time Frame: measured at the time of colonoscopy
    • total colonoscopy procedure time
  • Polyps Detected
    • Time Frame: measured at the time of colonoscopy
    • Number of polyps

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brooke Army Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joel Z. Stengel, Gastroenterology Fellow – Brooke Army Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.