Preparation for ColonoscopyPhase 4NCT01063049

Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

A Phase 4 study testing Gatorade/Miralax, NuLytely and Bisacodyl in people with Preparation for Colonoscopy, run by Gastroenterology Services, Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Preparation for Colonoscopy
What is being tested?: Gatorade/Miralax, NuLytely and Bisacodyl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Feb 2011
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

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Who cannot join

Patients who are allergic or intolerant to any on the study drugs.
Pregnant patients.
Patients who required multiple day colon preparation in the past.
Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gastroenterology Services
Downers Grove, Illinois, 60515

Other trials in United States

About this study

Official title: Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation

Conditions: Preparation for Colonoscopy
Being tested: Gatorade/Miralax, NuLytely, Bisacodyl, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gatorade/MiralaxDrug
Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
NuLytelyDrug
Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
BisacodylDrug
Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.
PlaceboDrug
Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy

Study groups in NCT01063049
Study group	Role	What they receive
Nulytely	Active comparator	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. Receives: Drug: NuLytely
Gatorade/Miralax + Placebo	Experimental	Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. Receives: Drug: Gatorade/Miralax; Drug: Placebo
Gatorade/Miralax + Bisacodyl	Experimental	Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. Receives: Drug: Gatorade/Miralax; Drug: Bisacodyl

What is being measured

The primary outcome is the main question the study is designed to answer.

The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).
Measured: After Colonoscopy

Secondary outcomes (1)

The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature
Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).
Measured: After Colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Feb 2011

First posted5 Feb 2010 (estimated)
Study startFeb 2010
Primary completionFeb 2011
Study completionFeb 2011

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 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: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01063049
Sponsor's protocol ID: 1220100180
Status last verified: Nov 2013
First submitted: 3 Feb 2010
Last updated: 18 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gerard DP, Holden JL, Foster DB, Raiser MW. Randomized Trial of Gatorade/Polyethylene Glycol With or Without Bisacodyl and NuLYTELY for Colonoscopy Preparation. Clin Transl Gastroenterol. 2012 Jun 21;3(6):e16. doi: 10.1038/ctg.2012.11.
PubMed 23238266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
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All Preparation for Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation
ClinicalTrials.gov ID: NCT01063049
Acronym / sponsor ID: 1220100180
Conditions: Preparation for Colonoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Gastroenterology Services, Ltd.University, hospital or other
Study start: Feb 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 5 Feb 2010 (estimated)
Results: Posted 18 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Nulytely	Active comparator	Drug: NuLytelyNulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Gatorade/Miralax + Placebo	Experimental	Drug: Gatorade/Miralax, Drug: PlaceboGatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
Gatorade/Miralax + Bisacodyl	Experimental	Drug: Gatorade/Miralax, Drug: BisacodylGatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Key exclusion criteria (4 listed)

Patients who are allergic or intolerant to any on the study drugs.
Pregnant patients.
Patients who required multiple day colon preparation in the past.
Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

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
Gatorade/MiralaxGatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Drug	Gatorade/Miralax + Bisacodyl, Gatorade/Miralax + Placebo
NuLytelyNulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Drug	Nulytely
BisacodylBisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.	Drug	Gatorade/Miralax + Bisacodyl
PlaceboPlacebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy	Drug	Gatorade/Miralax + Placebo

Primary outcome

The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
Time frame: After Colonoscopy
The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).

1 secondary outcome

The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature
Time frame: After Colonoscopy

Results and safety

Results posted to the registry on 18 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nulytely	200	200
Gatorade/Miralax + Placebo	200	200
Gatorade/Miralax + Bisacodyl	200	200

Primary outcome: The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale

Time frame: After Colonoscopy. Mean (Standard Deviation). Unit: units on a scale

Measure	Nulytely n = 200	Gatorade/Miralax + Placebo n = 200	Gatorade/Miralax + Bisacodyl n = 200
Value	7.86 (1.55)	8.05 (1.28)	7.99 (1.41)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 1 month after colonoscopy.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nulytely	0 of 200 (0%)	0 of 200 (0%)	Not reported
Gatorade/Miralax + Placebo	1 of 200 (0.5%)	0 of 200 (0%)	Not reported
Gatorade/Miralax + Bisacodyl	0 of 200 (0%)	0 of 200 (0%)	Not reported

Limitations and caveats (from the sponsor): Both the BBPS and OPS suffer from poorly designed scoring systems that are not easily converted into the poor/fair/good/excellent subjective rating scale, which is often used by gastroenterologists in their colonoscopy reports.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23238266Gerard DP, Holden JL, Foster DB, Raiser MW. Randomized Trial of Gatorade/Polyethylene Glycol With or Without Bisacodyl and NuLYTELY for Colonoscopy Preparation. Clin Transl Gastroenterol. 2012 Jun 21;3(6):e16. doi: 10.1038/ctg.2012.11.
On line publication of study resulting from this work.Link provided by the sponsor.

Related trials for Preparation for Colonoscopy

Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
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RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
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Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
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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 P Gerard, M.D. 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 Gatorade/Miralax, NuLytely and Bisacodyl in people with 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 4 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 18 Nov 2013. 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 18 Nov 2013). 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?

The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale (time frame: After Colonoscopy). 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 NCT01063049, 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 18 Nov 2013.