Trial Outcomes & Findings for Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep (NCT NCT01695863)
NCT ID: NCT01695863
Last Updated: 2023-08-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
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
Results posted on
2023-08-02
Participant Flow
A total of 150 patients were recruited and randomized to 75 patients in each arm. Of these, 128 patients arrived for the colonoscopy; therefore eligible to enter the final analysis.
To be able to enter a recruited patient into analysis, the consented patient must complete their colonoscopy. Of the 150 consented patients, 128 completed their colonoscopy while the remaining 22 did not. Those who did not complete their colonoscopy were excluded from analysis.
Participant milestones
| Measure |
Miralax
Miralax with Dulcolax and Gatorade given orally prior to surgery
|
Moviprep Split Dose
Split dose Moviprep given orally prior to surgery
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
66
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Baseline characteristics by cohort
| Measure |
Miralax
n=62 Participants
Miralax with Dulcolax and Gatorade given prior to surgery.
|
Moviprep Split Dose
n=66 Participants
Split dose Moviprep on cleansing colon given prior to surgery
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age > 18 Years
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 #2Population: A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel.
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 measures
| Measure |
Moviprep Split Dose
n=66 Participants
Split dose Moviprep - Given Orally
|
Miralax
n=62 Participants
miralax with dulcolax and gatorade
|
|---|---|---|
|
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
Left Colon
|
2.46 score on a scale
Standard Deviation 0.70
|
2.24 score on a scale
Standard Deviation 0.76
|
|
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
Right Colon
|
2.33 score on a scale
Standard Deviation .89
|
1.79 score on a scale
Standard Deviation 0.72
|
|
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
Transverse Colon
|
2.45 score on a scale
Standard Deviation 0.72
|
2.06 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: 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).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)
Outcome measures
| Measure |
Moviprep Split Dose
n=66 Participants
Split dose Moviprep - Given Orally
|
Miralax
n=62 Participants
miralax with dulcolax and gatorade
|
|---|---|---|
|
Renal Function Pre and Post Bowel Prep (mg/dL)
Glucose
|
3.44 Milligram per deciLiter (mg/dL)
Standard Deviation 45.44
|
1.41 Milligram per deciLiter (mg/dL)
Standard Deviation 45.44
|
|
Renal Function Pre and Post Bowel Prep (mg/dL)
Blood Urea Nitrogen
|
3.00 Milligram per deciLiter (mg/dL)
Standard Deviation 4.72
|
3.44 Milligram per deciLiter (mg/dL)
Standard Deviation 4.72
|
|
Renal Function Pre and Post Bowel Prep (mg/dL)
Calcium
|
0.02 Milligram per deciLiter (mg/dL)
Standard Deviation .53
|
0.18 Milligram per deciLiter (mg/dL)
Standard Deviation .53
|
|
Renal Function Pre and Post Bowel Prep (mg/dL)
Creatinine
|
-0.02 Milligram per deciLiter (mg/dL)
Standard Deviation 0.14
|
-0.01 Milligram per deciLiter (mg/dL)
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 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).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)
Outcome measures
| Measure |
Moviprep Split Dose
n=66 Participants
Split dose Moviprep - Given Orally
|
Miralax
n=62 Participants
miralax with dulcolax and gatorade
|
|---|---|---|
|
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Sodium
|
-0.92 Millimoles per Liter (mmol/L)
Standard Deviation 3.28
|
0.27 Millimoles per Liter (mmol/L)
Standard Deviation 3.28
|
|
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Bicarbonate
|
2.14 Millimoles per Liter (mmol/L)
Standard Deviation 4.29
|
1.43 Millimoles per Liter (mmol/L)
Standard Deviation 4.29
|
|
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Potassium
|
-0.11 Millimoles per Liter (mmol/L)
Standard Deviation 0.74
|
-0.18 Millimoles per Liter (mmol/L)
Standard Deviation 0.74
|
|
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Chloride
|
-0.44 Millimoles per Liter (mmol/L)
Standard Deviation 3.41
|
0.54 Millimoles per Liter (mmol/L)
Standard Deviation 3.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During Bowel Preparation (Pre-Operative)Population: These are self-report measures and not all subject submitted or complete the self report measures. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
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.
Outcome measures
| Measure |
Moviprep Split Dose
n=51 Participants
Split dose Moviprep - Given Orally
|
Miralax
n=43 Participants
miralax with dulcolax and gatorade
|
|---|---|---|
|
Non-Serious Adverse Events on Self Report Scale
Nausea
|
0.3152 score on a scale
Standard Deviation 0.61
|
0.3590 score on a scale
Standard Deviation 0.77
|
|
Non-Serious Adverse Events on Self Report Scale
Vomiting
|
0.0000 score on a scale
Standard Deviation 0.0000
|
0.2821 score on a scale
Standard Deviation 0.85
|
|
Non-Serious Adverse Events on Self Report Scale
Bloating
|
0.4565 score on a scale
Standard Deviation 0.72
|
0.6667 score on a scale
Standard Deviation 0.89
|
|
Non-Serious Adverse Events on Self Report Scale
Abdominal pain or cramping
|
0.3043 score on a scale
Standard Deviation 0.66
|
0.359 score on a scale
Standard Deviation 0.66
|
|
Non-Serious Adverse Events on Self Report Scale
Ability to complete entire prep
|
1.8511 score on a scale
Standard Deviation 0.46
|
1.878 score on a scale
Standard Deviation 0.39
|
|
Non-Serious Adverse Events on Self Report Scale
Difficulty/Inconvenience in completing prep
|
0.6596 score on a scale
Standard Deviation 0.75
|
0.6098 score on a scale
Standard Deviation 0.80
|
Adverse Events
Miralax
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Moviprep Split Dose
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Miralax
n=43 participants at risk；n=62 participants at risk
miralax with dulcolax and gatorade Condition
|
Moviprep Split Dose
n=51 participants at risk；n=66 participants at risk
Split dose moviprep Condition
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
27.9%
12/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
27.5%
14/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
6/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
0.00%
0/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
|
Gastrointestinal disorders
Bloating
|
51.2%
22/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
35.3%
18/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
|
Gastrointestinal disorders
Abdominal Pain or Cramping
|
30.2%
13/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
23.5%
12/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
|
Product Issues
Inability to Complete Prep
|
2.3%
1/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
3.9%
2/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
|
Product Issues
Difficulty in Completing Prep
|
48.8%
21/43 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
54.9%
28/51 • 8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
|
Additional Information
Maqsood Khan MD FACG
Aurora Gastroenterology, West Allis WI
Phone: 414-328-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place