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Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

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ClinicalTrials.gov Identifier: NCT01695863
Recruitment Status : Unknown
Verified March 2013 by Maqsood Khan, Rush University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2012
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
Maqsood Khan, Rush University Medical Center

Brief Summary:
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy Phase 4

Detailed Description:
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Study Start Date : February 2012
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: miralax
miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
the effects of the drug on the colon preparation for colonoscopy
Experimental: moviprep split dose
Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen
Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
the effects of the drug on the colon preparation for colonoscopy



Primary Outcome Measures :
  1. bowel prep efficacy [ Time Frame: 8 months ]
    To assess the bowel prep efficacy in cleansing the colon for colonoscopy


Secondary Outcome Measures :
  1. assess change in renal function pre and post bowel prep [ Time Frame: 8 months ]
    changes in electrolytes pre and post bowel preparation administration



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • outpatient colonoscopy for screening for other Gi related problems

Exclusion Criteria:

  • Severe CHF,
  • CKD,
  • less than age 18 or more than 80 years

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): NCT01695863


Locations
United States, Illinois
Rush Unversity Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Maqsood A Khan, MD Rush University Medical Center
Study Chair: Ali Keshavarzian, MD RUMC
Study Director: Michael D Brown, MD RUMC
Principal Investigator: John losurdo, MD Rush University Medical Center

Additional Information:
Publications:
Responsible Party: Maqsood Khan, GI fellow, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01695863     History of Changes
Other Study ID Numbers: 11042705
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: March 2013

Keywords provided by Maqsood Khan, Rush University Medical Center:
Miralax with gatorade and dulcolax
Movi pre
Patient satisfaction and efficacy

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
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents