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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Z. Stengel, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00953017
First received: August 5, 2009
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Colonoscopy
Drug: Miralax (PEG 3350)
Drug: Amitiza (Lubiprostone)
Drug: Dulcolax (Bisacodyl)
Drug: Golytely (polyethylene glycol)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • The Cleanliness of the Prep as Measured by the Ottawa Scale [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]
    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:
  • Patient Satisfaction With the Prep Measured by 5 Point Likert Scale [ Time Frame: measured at check in to colonoscopy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    total colonoscopy procedure time

  • Polyps Detected [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]
    Number of polyps


Enrollment: 425
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953017

Locations
United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78248
Sponsors and Collaborators
Brooke Army Medical Center
  More Information

No publications provided by Brooke Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joel Z. Stengel, Gastroenterology Fellow, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00953017     History of Changes
Other Study ID Numbers: C.2009.209
Study First Received: August 5, 2009
Results First Received: September 6, 2012
Last Updated: November 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Efficacy of bowel cleansing
Patient tolerability
Amitiza
Dulcolax
Miralax
Colonoscopy preparation
Bowel preparation
Screening colonoscopy

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014