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Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maqsood Khan, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01695863
First received: August 10, 2012
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • bowel prep efficacy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    To assess the bowel prep efficacy in cleansing the colon for colonoscopy


Secondary Outcome Measures:
  • assess change in renal function pre and post bowel prep [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    changes in electrolytes pre and post bowel preparation administration


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 10, 2012
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 24, 2014