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CompletedNCT01719653Updated Mar 24, 2017Results posted

A Comparison of 5 Low Volume Bowel Preparations

A Phase 4 interventional study of MiraLAX and Gatorade in Bowel Preparation for Colonoscopy, sponsored by Gastroenterology Services, Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Gastroenterology Services, Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,079
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

02

Conditions studied

  • Bowel Preparation for Colonoscopy

Keywords

  • Colonoscopy
  • Bowel Preparation
  • MiraLAX
  • Gatorade
  • PEG-3350
  • MoviPrep
  • SUPREP
  • Chicago Bowel Preparation Scale
  • Boston Bowel Preparation Scale
03

In context

Lead sponsor

Gastroenterology Services, Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
  2. Patients who are pregnant.
  3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
  4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
  5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
1,079 participants (actual)

Study arms

  • Active comparator
    MiraLAX 306 g (Day-Prior)

    MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM

    Drug: MiraLAX · Other: Gatorade

  • Experimental
    MiraLAX 357 g (Day-Prior)

    MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.

    Drug: MiraLAX · Other: Gatorade

  • Experimental
    MiraLAX 306 g (Split-Dose)

    MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.

    Drug: MiraLAX · Other: Gatorade

  • Active comparator
    MoviPrep (Split-Dose)

    MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.

    Drug: MoviPrep

  • Active comparator
    SUPREP (Split-Dose)

    SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.

    Drug: SUPREP

Interventions

  • DrugMiraLAX

    MiraLAX consumed as described in each arm.

    Also known as: PEG-3350

  • OtherGatorade

    Gatorade consumed as described in each arm.

  • DrugMoviPrep

    MoviPrep consumed as described in each arm.

  • DrugSUPREP

    SUPREP consumed as described in each arm.

06

What researchers measure

Primary outcomes

  1. Chicago Bowel Preparation Scale

    The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

    Time frame: At completion of colonoscopy - day 1

Secondary outcomes

  1. Boston Bowel Preparation Scale

    The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).

    Time frame: At completion of colonoscopy - day 1

  2. Adequate/Inadequate Scale

    The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.

    Time frame: At completion of colonoscopy - day 1

07

Results

Posted Mar 24, 2017

Participant flow

Participant flow — Overall Study
MilestoneMiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)
Started209213218218221
Completed200200200200200
Not completed913181821

Outcome measures

PrimaryChicago Bowel Preparation Scale

The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

Time frame:
At completion of colonoscopy - day 1
Reported as:
Mean · units on a scale
Chicago Bowel Preparation Scale
units on a scaleMiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)
Chicago BPS Total Score33.54 ± 4.2834.00 ± 4.2534.67 ± 3.5834.95 ± 3.3935.16 ± 2.34
Modified Chicago BPS Total Score31.82 ± 3.5932.14 ± 3.6932.33 ± 2.9332.54 ± 2.9232.65 ± 1.72
Chicago BPS Fluid Score0.90 ± 0.831.03 ± 0.891.84 ± 0.901.45 ± 0.821.30 ± 0.91
Statistical analysis
  • MiraLAX 306 g (Day-Prior) vs MiraLAX 357 g (Day-Prior) vs MiraLAX 306 g (Split-Dose) vs MoviPrep (Split-Dose) vs SUPREP (Split-Dose) · t-test, 2 sided · p = <0.005 (Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.)
SecondaryBoston Bowel Preparation Scale

The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).

Time frame:
At completion of colonoscopy - day 1
Reported as:
Mean · units on a scale
Boston Bowel Preparation Scale
units on a scaleMiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)
Boston Bowel Preparation Scale8.39 ± 1.368.57 ± 1.168.66 ± 1.168.80 ± 1.048.80 ± 0.77
Statistical analysis
  • MiraLAX 306 g (Day-Prior) vs MiraLAX 357 g (Day-Prior) vs MiraLAX 306 g (Split-Dose) vs MoviPrep (Split-Dose) vs SUPREP (Split-Dose) · t-test, 2 sided · p = <0.001 (1 was lower than 4,5.)
SecondaryAdequate/Inadequate Scale

The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.

Time frame:
At completion of colonoscopy - day 1
Reported as:
Count of participants · Participants
Adequate/Inadequate Scale
ParticipantsMiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)
Adequate195196198197197
Inadequate54233
Statistical analysis
  • MiraLAX 306 g (Day-Prior) vs MiraLAX 357 g (Day-Prior) vs MiraLAX 306 g (Split-Dose) vs MoviPrep (Split-Dose) vs SUPREP (Split-Dose) · Chi-squared · p = >0.005

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MiraLAX 306 g (Day-Prior)0/200 (0%)0/200 (0%)119/200 (59.5%)
MiraLAX 357 g (Day-Prior)0/200 (0%)0/200 (0%)122/200 (61%)
MiraLAX 306 g (Split-Dose)0/200 (0%)0/200 (0%)126/200 (63%)
MoviPrep (Split-Dose)0/200 (0%)0/200 (0%)110/200 (55%)
SUPREP (Split-Dose)0/200 (0%)0/200 (0%)111/200 (55.5%)
Most frequent other events
Most frequent other events
EventMiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)
BloatingGastrointestinal disorders119/200122/200126/200110/200111/200
NauseaGastrointestinal disorders65/20080/20066/20065/20070/200
Abdominal Cramps/PainGastrointestinal disorders66/20070/20068/20075/20078/200
VomitingGastrointestinal disorders18/20023/20012/2008/20013/200

Baseline characteristics

Age, Continuous
Age, Continuous(years)MiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)Total
Mean60.9 ± 12.761.3 ± 12.459.1 ± 11.360.1 ± 11.460.6 ± 11.260.4 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)MiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)Total
Female99991019799495
Male10110199103101505
Region of Enrollment
Region of Enrollment(participants)MiraLAX 306 g (Day-Prior)MiraLAX 357 g (Day-Prior)MiraLAX 306 g (Split-Dose)MoviPrep (Split-Dose)SUPREP (Split-Dose)Total
United States2002002002002001000
08

Study locations

1 site
  • Gastroenterology Services
    Downers Grove, Illinois 60515, United States
09

References and documents

Publications

  • Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2017 Jul;51(6):512-521. doi: 10.1097/MCG.0000000000000575. PubMed 27433812 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2012, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 2 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2012
First posted
Nov 1, 2012
Start
Oct 2012
Primary completionActual
Sep 2014
CompletionActual
Sep 2014
Results first posted
Mar 24, 2017
Last update
Mar 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01719653
Lead sponsor
Gastroenterology Services, Ltd.
Responsible party
Sponsor
First posted
Nov 1, 2012
Start date
Oct 2012
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Mar 24, 2017
Last update
Mar 24, 2017

Study contacts

David Gerard, MD
principal investigator · Gastroenterology Services, Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Polyethylene glycol 3350

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Gastroenterology Services, Ltd.

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