Bowel Preparation for ColonoscopyPhase 4NCT01719653
A Comparison of 5 Low Volume Bowel Preparations
A Phase 4 study testing MiraLAX, Gatorade and MoviPrep in people with Bowel Preparation for Colonoscopy, run by Gastroenterology Services, Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- MiraLAX, Gatorade and MoviPrep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,079 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
- Patients who are pregnant.
- Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
- Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Services
Downers Grove, Illinois, 60515
About this study
Official title: A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
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.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- MiraLAX, Gatorade, MoviPrep, SUPREP
- Keywords
- Colonoscopy, Bowel Preparation, MiraLAX, Gatorade, PEG-3350, MoviPrep, SUPREP, Chicago Bowel Preparation Scale, Boston Bowel Preparation Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraLAXDrug
Also called PEG-3350
MiraLAX consumed as described in each arm.
GatoradeOther
Gatorade consumed as described in each arm.
MoviPrepDrug
MoviPrep consumed as described in each arm.
SUPREPDrug
SUPREP consumed as described in each arm.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: MiraLAX; Other: Gatorade |
| 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. Receives: Drug: MiraLAX; Other: Gatorade |
| 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. Receives: Drug: MiraLAX; Other: Gatorade |
| 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. Receives: Drug: MoviPrep |
| SUPREP (Split-Dose) | 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. Receives: Drug: SUPREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At completion of colonoscopy - day 1
Secondary outcomes (2)
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).
Measured: At completion of colonoscopy - day 1
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.
Measured: At completion of colonoscopy - day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastroenterology Services, Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Gerard, MD, Principal investigator, Gastroenterology Services, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719653
- Sponsor's protocol ID
- 1220121180
- Status last verified
- Mar 2017
- First submitted
- 28 Oct 2012
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
- ClinicalTrials.gov ID
- NCT01719653
- Acronym / sponsor ID
- 1220121180
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- Colonoscopy, Bowel Preparation, MiraLAX, Gatorade, PEG-3350, MoviPrep, SUPREP, Chicago Bowel Preparation Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- Gastroenterology Services, Ltd.University, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MiraLAX 306 g (Day-Prior) | Active comparator | Drug: MiraLAX, Other: GatoradeMiraLAX 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 | Drug: MiraLAX, Other: GatoradeMiraLAX 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 | Drug: MiraLAX, Other: GatoradeMiraLAX 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 | Drug: MoviPrepMoviPrep 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) | Active comparator | Drug: SUPREPSUPREP 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
- Patients who are pregnant.
- Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
- Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraLAXAlso: PEG-3350MiraLAX consumed as described in each arm. | Drug | MiraLAX 306 g (Day-Prior), MiraLAX 306 g (Split-Dose), MiraLAX 357 g (Day-Prior) |
| GatoradeGatorade consumed as described in each arm. | Other | MiraLAX 306 g (Day-Prior), MiraLAX 306 g (Split-Dose), MiraLAX 357 g (Day-Prior) |
| MoviPrepMoviPrep consumed as described in each arm. | Drug | MoviPrep (Split-Dose) |
| SUPREPSUPREP consumed as described in each arm. | Drug | SUPREP (Split-Dose) |
Primary outcome
Chicago Bowel Preparation Scale
Time frame: At completion of colonoscopy - day 1
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).
2 secondary outcomes
Boston Bowel Preparation Scale
Time frame: At completion of colonoscopy - day 1
Adequate/Inadequate Scale
Time frame: At completion of colonoscopy - day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27433812Gerard 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gerard, MD principal investigator
Gastroenterology Services, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MiraLAX, Gatorade and MoviPrep in people with Bowel Preparation for Colonoscopy, run by Gastroenterology Services, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chicago Bowel Preparation Scale (time frame: At completion of colonoscopy - day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.