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

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ClinicalTrials.gov Identifier: NCT02523911
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mercy Medical Center, Des Moines, Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Simethicone Drug: Placebo Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
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 Name: 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: 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 Name: Inert solution

Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution
Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
Other Name: Suprep Bowel Prep Kit




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02523911


Contacts
Contact: Tercio Lopes, MD Limongister@gmail.com

Locations
United States, Florida
UF Health Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32209
Contact: Asim Shuja, MD    617-842-9989    asim.shuja@jax.ufl.edu   
Principal Investigator: Silvio de Melo, MD         
United States, Iowa
Iowa Endoscopy Center Recruiting
Clive, Iowa, United States, 50325
Contact: Laura L Ulmer, DO    515-473-1762    lulmer@mercydesmoines.org   
Contact: Neha Vohra, DO    515-443-6391    NVohra@mercydesmoines.org   
Sub-Investigator: Laura L Ulmer, DO         
Sub-Investigator: Neha Vohra, DO         
Principal Investigator: Tercio Lopes, MD         
Sponsors and Collaborators
Mercy Medical Center, Des Moines, Iowa
Investigators
Principal Investigator: Tercio Lopes, MD Iowa Digestive Disease Center
Principal Investigator: Silvio de Melo, MD University of Florida Health Systems, Jacksonville

Publications:

Responsible Party: Mercy Medical Center, Des Moines, Iowa
ClinicalTrials.gov Identifier: NCT02523911     History of Changes
Other Study ID Numbers: MMC2015-31
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Mercy Medical Center, Des Moines, Iowa:
Suprep
Simethicone
Colorectal cancer screening
Routine colonoscopy
sodium sulfate/potassium sulfate/magnesium sulfate
Bowel cleansing
Mass screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmaceutical Solutions
Magnesium Sulfate
Simethicone
Sodium sulfate
Cathartics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Antifoaming Agents