Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

February 10, 2020 updated by: MercyOne Des Moines Medical Center

Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

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Withdrawn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

The study will investigate sodium sulfate/potassium sulfate/magnesium sulfate (Suprep), with and without simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy. Adult ambulatory outpatients who are scheduled for elective routine colonoscopy for colorectal cancer screening will be recruited to participate in the trial. Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep) and will receive verbal and written instruction on administration of solutions. During colonoscopy, three areas of the colon (right colon, transverse colon, and left colon) will be assessed during removal of the colonoscope for overall colon cleansing, presence of bubbles, and degree of haziness; this will be scored by a blinded endoscopist. A separate written patient questionnaire will be used to assess acceptability and tolerability of the preparation, as well as any adverse events.

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
    • Florida
      • Jacksonville, Florida, United States, 32209
        • UF Health Jacksonville
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Endoscopy Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Outpatients who require elective colonoscopy for colorectal cancer screening at Iowa Endoscopy Center and at University of Florida - Jacksonville

Exclusion Criteria:

  • Allergy or hypersensitivity to any constituent of the lavage solution or to simethicone
  • Presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart failure, New York Heart Association classification III-IV, history of myocardial infarction within 6 months, coagulopathy)
  • Massive ascites
  • Renal insufficiency
  • Pregnancy
  • History of colonic surgery
  • History of anti-flatulence or laxative agent within one week
  • Refusal/inability to give consent
  • Patients undergoing colonoscopy for reasons other than colorectal cancer screening
  • Mentally disabled
  • Non-English-speaking patients

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 Assignment
  • Masking: Triple

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: Simethicone Group
Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL simethicone in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.
Drug: Simethicone
Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
Other Names:
  • Gas-X Infant Drops
  • Infants Gas Relief
  • Infants Simethicone
  • Infants' Mylicon
Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution
Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
Other Names:
  • Suprep Bowel Prep Kit
Placebo Comparator: Placebo Group
Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL of placebo (identical in appearance to simethicone) in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.
Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution
Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
Other Names:
  • Suprep Bowel Prep Kit
Drug: Placebo
Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
Other Names:
  • Inert solution

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
Measure Description
Time Frame
Overall bowel cleansing
Time Frame: During procedure
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
During 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
Number of patients with adverse effects
Time Frame: Day prior to and day of colonoscopy
A written patient questionnaire will be used to assess patient acceptability and tolerability by recording any adverse effects experienced, including nausea, vomiting, headache, insomnia, bloating, abdominal pain, abdominal discomfort, abdominal cramps or any others.
Day prior to and day of colonoscopy
Number of patients completing the bowel preparation
Time Frame: Day prior to and day of colonoscopy
A written patient questionnaire will be used to assess compliance by asking if the total prescribed volume of solution was ingested and by recording number of evacuations.
Day prior to and day of colonoscopy

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence of bubbles
Time Frame: During procedure
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
During procedure
Degree of haziness
Time Frame: During procedure
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
During procedure

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.
MercyOne Des Moines Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tercio Lopes, MD, Iowa Digestive Disease Center
  • Principal Investigator: Silvio de Melo, MD, University of Florida Health Systems, Jacksonville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
March 1, 2016

Primary Completion (Actual)

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.
December 1, 2017

Study Completion (Actual)

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.
December 1, 2017

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).
August 12, 2015

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.
August 13, 2015

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.
August 14, 2015

Study Record Updates

Last Update Posted (Actual)

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.
February 12, 2020

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.
February 10, 2020

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.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • MMC2015-31

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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