Title

Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    150
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon
Study Started
Feb 29
2012
Primary Completion
Nov 30
2012
Study Completion
Jan 31
2014
Results Posted
Aug 02
2023
Last Update
Aug 02
2023

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

the effects of the drug on the colon preparation for colonoscopy

miralax Experimental

miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire

moviprep split dose Experimental

Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen

Criteria

Inclusion Criteria:

outpatient colonoscopy for screening for other Gi related problems

Exclusion Criteria:

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

Summary

Miralax

Moviprep Split Dose

All Events

Event Type Organ System Event Term Miralax Moviprep Split Dose

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.

Miralax

Left Colon

2.24
score on a scale (Mean)
Standard Deviation: 0.76

Right Colon

1.79
score on a scale (Mean)
Standard Deviation: 0.72

Transverse Colon

2.06
score on a scale (Mean)
Standard Deviation: 0.79

Moviprep Split Dose

Left Colon

2.46
score on a scale (Mean)
Standard Deviation: 0.70

Right Colon

2.33
score on a scale (Mean)
Standard Deviation: .89

Transverse Colon

2.45
score on a scale (Mean)
Standard Deviation: 0.72

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

Changes in electrolytes pre and post bowel preparation administration. 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). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)

Miralax

Blood Urea Nitrogen

3.44
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 4.72

Calcium

0.18
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: .53

Creatinine

-0.01
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 0.14

Glucose

1.41
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 45.44

Moviprep Split Dose

Blood Urea Nitrogen

3.0
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 4.72

Calcium

0.02
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: .53

Creatinine

-0.02
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 0.14

Glucose

3.44
Milligram per deciLiter (mg/dL) (Mean)
Standard Deviation: 45.44

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

Changes in electrolytes pre and post bowel preparation administration. 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). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)

Miralax

Bicarbonate

1.43
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 4.29

Chloride

0.54
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 3.41

Potassium

-0.18
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 0.74

Sodium

0.27
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 3.28

Moviprep Split Dose

Bicarbonate

2.14
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 4.29

Chloride

-0.44
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 3.41

Potassium

-0.11
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 0.74

Sodium

-0.92
Millimoles per Liter (mmol/L) (Mean)
Standard Deviation: 3.28

Non-Serious Adverse Events on Self Report Scale

Non-Serious Adverse Events on self report scale - 5 point scale from "No Complaints (0)" to "Very Severe (4)" with 4 indicating the worst outcome and 0 the best.

Miralax

Abdominal pain or cramping

0.359
score on a scale (Mean)
Standard Deviation: 0.66

Ability to complete entire prep

1.878
score on a scale (Mean)
Standard Deviation: 0.39

Bloating

0.6667
score on a scale (Mean)
Standard Deviation: 0.89

Difficulty/Inconvenience in completing prep

0.6098
score on a scale (Mean)
Standard Deviation: 0.80

Nausea

0.359
score on a scale (Mean)
Standard Deviation: 0.77

Vomiting

0.2821
score on a scale (Mean)
Standard Deviation: 0.85

Moviprep Split Dose

Abdominal pain or cramping

0.3043
score on a scale (Mean)
Standard Deviation: 0.66

Ability to complete entire prep

1.8511
score on a scale (Mean)
Standard Deviation: 0.46

Bloating

0.4565
score on a scale (Mean)
Standard Deviation: 0.72

Difficulty/Inconvenience in completing prep

0.6596
score on a scale (Mean)
Standard Deviation: 0.75

Nausea

0.3152
score on a scale (Mean)
Standard Deviation: 0.61

Vomiting

Total

128
Participants

Age, Customized

Sex: Female, Male

Overall Study

Miralax

Moviprep Split Dose