Colorectal CancerPhase 4NCT01695863

Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

A Phase 4 study testing comparing 2 drugs on their effect on the bowel preparation for colonoscopy in people with Colorectal Cancer, run by Rush University Medical Center 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

This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Jan 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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

outpatient colonoscopy for screening for other Gi related problems

Who cannot join

Severe Congestive Heart Failure (CHF),
Chronic Kidney Disease (CKD),
less than age 18 or more than 80 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush Unversity Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Read the detailed description

Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Conditions: Colorectal Cancer
Being tested: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Keywords: Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy
Medical subject headings: Colorectal Neoplasms, Patient Satisfaction

What participants receive

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

comparing 2 drugs on their effect on the bowel preparation for colonoscopyDrug
the effects of the drug on the colon preparation for colonoscopy

Study groups in NCT01695863
Study group	Role	What they receive
miralax	Experimental	miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire Receives: Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
moviprep split dose	Experimental	Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen Receives: Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy

What is being measured

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

Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
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.
Measured: 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

Secondary outcomes (2)

Renal Function Pre and Post Bowel Prep (mg/dL)
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)
Measured: 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).
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
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)
Measured: 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).

Timeline

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

Feb 2012Jan 2014

First posted28 Sep 2012 (estimated)
Study startFeb 2012
Primary completionNov 2012
Study completionJan 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 (3)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01695863
Sponsor's protocol ID: 11042705
Status last verified: Aug 2023
First submitted: 10 Aug 2012
Last updated: 2 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
PubMed 12135020
Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
PubMed 17299615
DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x.
PubMed 14572566

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
ClinicalTrials.gov ID: NCT01695863
Acronym / sponsor ID: 11042705
Conditions: Colorectal Cancer
Keywords: Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: Feb 2012
Primary completion: Nov 2012 (actual)
Study completion: Jan 2014 (actual)
First posted: 28 Sep 2012 (estimated)
Results: Posted 2 Aug 2023

Clinical summary

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

This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Detailed description

Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
miralax	Experimental	Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopymiralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
moviprep split dose	Experimental	Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopyEfficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

outpatient colonoscopy for screening for other Gi related problems

Key exclusion criteria (3 listed)

Severe Congestive Heart Failure (CHF),
Chronic Kidney Disease (CKD),
less than age 18 or more than 80 years

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
comparing 2 drugs on their effect on the bowel preparation for colonoscopythe effects of the drug on the colon preparation for colonoscopy	Drug	miralax, moviprep split dose

Primary outcome

Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
Time frame: 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
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.

2 secondary outcomes

Renal Function Pre and Post Bowel Prep (mg/dL)
Time frame: 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).
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Time frame: 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).

Results and safety

Results posted to the registry on 2 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Miralax	62	62
Moviprep Split Dose	66	66

Primary outcome: Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)

Time frame: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Miralax n = 62	Moviprep Split Dose n = 66
Right Colon	1.79 (0.72)	2.33 (.89)
Transverse Colon	2.06 (0.79)	2.45 (0.72)
Left Colon	2.24 (0.76)	2.46 (0.70)

Miralax vs Moviprep Split Dose: Mean Difference (Final Values): .54 (95% CI 0.269 to 0.816), p <0.0001, t-test, 2 sided
Miralax vs Moviprep Split Dose: Mean Difference (Final Values): 0.39 (95% CI 0.122 to 0.655), p = 0.005, t-test, 2 sided
Miralax vs Moviprep Split Dose: Mean Difference (Final Values): 0.22 (95% CI -0.029 to 0.484), p = 0.08, t-test, 2 sided

Population analysed: A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Miralax	0 of 62 (0%)	22 of 43 (51.2%)	0 of 62
Moviprep Split Dose	0 of 66 (0%)	28 of 51 (54.9%)	0 of 66

Limitations and caveats (from the sponsor): No systematic recording of incidence for non-serious adverse events were collected by study personnel or subjects, so details on event occurrence cannot be provided. Adverse events on a self-report scale of severity are recorded the table names: "Non-Serious Adverse Events on Self Report Scale" and provide an index of the perceived impact of non-serious adverse events on the subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12135020Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
Background: PubMed 17299615Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
Background: PubMed 14572566DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x.
rush university medical center websiteLink provided by the sponsor.

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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.

Maqsood A Khan, MD principal investigator

Rush University Medical Center

Ali Keshavarzian, MD study chair

RUMC

Michael D Brown, MD study director

RUMC

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 comparing 2 drugs on their effect on the bowel preparation for colonoscopy in people with Colorectal Cancer, run by Rush University Medical Center 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 3 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 2 Aug 2023. 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 2 Aug 2023). 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?

Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) (time frame: 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). 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 NCT01695863, which also lists 3 linked publications.

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 2 Aug 2023.