Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

NCT01695863 | Completed Phase 4 Results DMC

• 1 other identifier: 11042705
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

Miralax with gatorade and dulcolax; Movi pre; Patient satisfaction and efficacy

Outcome Measures

Primary Outcomes (1)

• Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)

  To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.

  Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2

Secondary Outcomes (2)

• Renal Function Pre and Post Bowel Prep (mg/dL)

  Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).

• Renal Function Pre and Post Bowel Prep - Continued (mmol/L)

  Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).

Other Outcomes (1)

• Non-Serious Adverse Events on Self Report Scale

  During Bowel Preparation (Pre-Operative)

Study Arms (2)

miralax

EXPERIMENTAL

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

moviprep split dose

EXPERIMENTAL

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

Interventions

comparing 2 drugs on their effect on the bowel preparation for colonoscopy DRUG

the effects of the drug on the colon preparation for colonoscopy

miralax; moviprep split dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatient colonoscopy for screening for other Gi related problems

You may not qualify if:

• Severe Congestive Heart Failure (CHF),
• Chronic Kidney Disease (CKD),
• less than age 18 or more than 80 years

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush Unversity Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• 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. doi: 10.1111/j.1572-0241.2002.05827.x.

  PMID: 12135020 BACKGROUND

• Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.

  PMID: 17299615 BACKGROUND

• DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. 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. doi: 10.1111/j.1572-0241.2003.07690.x.

  PMID: 14572566 BACKGROUND

Related Links

• rush university medical center website

MeSH Terms

Conditions

Colorectal Neoplasms; Patient Satisfaction

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

No systematic recording of incidence for non-serious adverse events were collected by study personnel or subjects, so details on event occurrence cannot be provided. Adverse events on a self-report scale of severity are recorded the table names: "Non-Serious Adverse Events on Self Report Scale" and provide an index of the perceived impact of non-serious adverse events on the subjects.

Results Point of Contact

• Title: Maqsood Khan MD FACG
• Organization: Aurora Gastroenterology, West Allis WI

mkhangi@yahoo.com

414-328-8750

Study Officials

• Maqsood A Khan, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Ali Keshavarzian, MD

  RUMC

  STUDY CHAIR

• Michael D Brown, MD

  RUMC

  STUDY DIRECTOR

• John losurdo, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: September 28, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2014
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-08

Locations

US (1)