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

July 9, 2015 updated by: Zachary Smith, Medical College of Wisconsin

Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
Drug: PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Prepopik

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00022505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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