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Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

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ClinicalTrials.gov Identifier: NCT02124447
Recruitment Status : Withdrawn (Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB)
First Posted : April 28, 2014
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Zachary Smith, Medical College of Wisconsin

Brief Summary:
This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

Condition or disease Intervention/treatment Phase
Patients Undergoing Screening or Surveillance Colonoscopy Drug: PEG+E Drug: PEG+Asc Drug: P+MC Drug: sulfate Not Applicable

Detailed Description:

We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include

  1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
  2. Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
  3. Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
  4. Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Official Title: Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
Study Start Date : June 2014
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
Drug: PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
Other Name: Golytely

Active Comparator: PEG+Asc
Split dose 2 liter polyethylene glycol with ascorbic acid
Drug: PEG+Asc
Split dose 2 liter polyethylene glycol with ascorbic acid
Other Name: MoviPrep

Active Comparator: P+MC
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
Drug: P+MC
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
Other Name: Suprep

Active Comparator: sulfate
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
Drug: sulfate
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
Other Name: Prepopik




Primary Outcome Measures :
  1. Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS) [ Time Frame: Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure ]

Secondary Outcome Measures :
  1. Patient tolerability and satisfaction [ Time Frame: Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter ]
    Will be assessed using a previously studied satisfaction questionnaire (7 items)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or greater
  2. Ability to understand and complete questionnaires
  3. Ability to speak and read English
  4. Willingness to participate in study
  5. Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes

Exclusion Criteria:

  1. Previous bowel resection of any kind (small or large bowel)
  2. End stage renal disease (ESRD)
  3. Contraindication to bowel purgative
  4. Necessity for inpatient admission to receive bowel preparation for any reason
  5. Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
  6. Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
  7. Subject did not follow appropriate dosing instructions for bowel purgative
  8. Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
  9. History of colon polyposis syndrome
  10. Personal history of inflammatory bowel disease
  11. History of inadequate colon preparation on any prior colonoscopies
  12. Patient is pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124447


Locations
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United States, Wisconsin
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Responsible Party: Zachary Smith, Division of Gastroenterology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02124447    
Other Study ID Numbers: PRO00022505
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015