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

History of Changes

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:

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

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

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:

rush university medical center website This link exits the ClinicalTrials.gov site

Publications:

Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700.

Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. Review.

DiPalma JA, Wolff BG, Meagher A, Cleveland M. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91.

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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