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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiraLAX 306 g (Day-Prior) | Active Comparator | 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 |
|
| MiraLAX 357 g (Day-Prior) | Experimental | 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. |
|
| MiraLAX 306 g (Split-Dose) | Experimental | 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. |
|
| MoviPrep (Split-Dose) | Active Comparator | 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. |
|
| SUPREP (Split-Dose) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiraLAX | Drug | MiraLAX consumed as described in each arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At completion of colonoscopy - day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At completion of colonoscopy - day 1 |
| Adequate/Inadequate Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gerard, MD | Gastroenterology Services, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Services | Downers Grove | Illinois | 60515 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27433812 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| FG001 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| FG002 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| FG003 | 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. MoviPrep: MoviPrep consumed as described in each arm. |
| FG004 | 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. SUPREP: SUPREP consumed as described in each arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | At completion of colonoscopy - day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Gerard, MD | Gastroenterology Services, Ltd | 630 969 1167 | davidpgerard@comcast.net |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| C011259 | gatorade |
| C520497 | MoviPrep |
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| Active Comparator |
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. |
|
|
| Gatorade | Other | Gatorade consumed as described in each arm. |
|
| MoviPrep | Drug | MoviPrep consumed as described in each arm. |
|
| SUPREP | Drug | SUPREP consumed as described in each arm. |
|
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.
| At completion of colonoscopy - day 1 |
| 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| BG002 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| BG003 | 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. MoviPrep: MoviPrep consumed as described in each arm. |
| BG004 | 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. SUPREP: SUPREP consumed as described in each arm. |
| BG005 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| OG002 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. |
| OG003 | 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. MoviPrep: MoviPrep consumed as described in each arm. |
| OG004 | 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. SUPREP: SUPREP consumed as described in each arm. |
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|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | At completion of colonoscopy - day 1 |
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| Secondary | 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. | Posted | Count of Participants | Participants | At completion of colonoscopy - day 1 |
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| 0 |
| 200 |
| 0 |
| 200 |
| 119 |
| 200 |
| EG001 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. | 0 | 200 | 0 | 200 | 122 | 200 |
| EG002 | 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. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm. | 0 | 200 | 0 | 200 | 126 | 200 |
| EG003 | 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. MoviPrep: MoviPrep consumed as described in each arm. | 0 | 200 | 0 | 200 | 110 | 200 |
| EG004 | 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. SUPREP: SUPREP consumed as described in each arm. | 0 | 200 | 0 | 200 | 111 | 200 |
| Vomiting | Gastrointestinal disorders |
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| Abdominal Cramps/Pain | Gastrointestinal disorders |
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| Bloating | Gastrointestinal disorders |
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| Inadequate |
|