ColonoscopyPhase 4NCT00953017

A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

A Phase 4 study testing Miralax (PEG 3350), Amitiza (Lubiprostone) and Dulcolax (Bisacodyl) in people with Colonoscopy, run by Brooke Army 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Colonoscopy
What is being tested?: Miralax (PEG 3350), Amitiza (Lubiprostone) and Dulcolax (Bisacodyl)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 425 participants
Where: 1 siteUnited States
Study dates: Jul 2009to May 2010
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

adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Who cannot join

elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
previous diagnosis of congestive heart failure
history of bowel obstruction
history of solid organ transplant
current pregnancy
lactating mother
participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)

Trial locations and contacts

1 site in 1 country.

United States1 site

Brooke Army Medical Center
San Antonio, Texas, 78248

Other trials in United States

About this study

Official title: A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Conditions: Colonoscopy
Being tested: Miralax (PEG 3350), Amitiza (Lubiprostone), Dulcolax (Bisacodyl), Golytely (polyethylene glycol)
Keywords: Efficacy of bowel cleansing, Patient tolerability, Amitiza, Dulcolax, Miralax, Colonoscopy preparation, Bowel preparation, Screening colonoscopy

What participants receive

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

Miralax (PEG 3350)Drug
Miralax 255gm bottle
Amitiza (Lubiprostone)Drug
Amitiza 24mcg gelcap
Dulcolax (Bisacodyl)Drug
Bisacodyl 5mg tab x2
Golytely (polyethylene glycol)Drug
Golytely 1 gallon

Study groups in NCT00953017
Study group	Role	What they receive
Miralax plus Amitiza	Active comparator	106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. Receives: Drug: Amitiza (Lubiprostone)
Miralax plus Dulcolax	Active comparator	107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. Receives: Drug: Dulcolax (Bisacodyl)
Miralax	Active comparator	106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. Receives: Drug: Miralax (PEG 3350)
Golytely (polyethylene glycol)	Active comparator	106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy Receives: Drug: Golytely (polyethylene glycol)

What is being measured

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

The Cleanliness of the Prep as Measured by the Ottawa Scale
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.
Measured: measured at the time of colonoscopy

Secondary outcomes (3)

Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)
Measured: measured at check in to colonoscopy
Procedure Time
total colonoscopy procedure time
Measured: measured at the time of colonoscopy
Polyps Detected
Number of polyps
Measured: measured at the time of colonoscopy

Timeline

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

Jul 2009May 2010

First posted6 Aug 2009 (estimated)
Study startJul 2009
Primary completionMay 2010
Study completionMay 2010

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 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: Care provider
Enrolment: 425 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00953017
Sponsor's protocol ID: C.2009.209
Status last verified: Nov 2012
First submitted: 5 Aug 2009
Last updated: 30 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hjelkrem M, Stengel J, Liu M, Jones DP, Harrison SA. MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Clin Gastroenterol Hepatol. 2011 Apr;9(4):326-332.e1. doi: 10.1016/j.cgh.2010.11.007. Epub 2010 Nov 27.
PubMed 21115134

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

RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
Enrolling by invitation
The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy
Colonoscopy
Recruiting
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Adenoma Detection Rate, Colonoscopy

All Colonoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
ClinicalTrials.gov ID: NCT00953017
Acronym / sponsor ID: C.2009.209
Conditions: Colonoscopy
Keywords: Efficacy of bowel cleansing, Patient tolerability, Amitiza, Dulcolax, Miralax, Colonoscopy preparation, Bowel preparation, Screening colonoscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 425 participants (actual)
Lead sponsor: Brooke Army Medical CenterUS federal agency
Study start: Jul 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 30 Nov 2012

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 (care provider)
Number of arms: 4

Arm	Type	Receives
Miralax plus Amitiza	Active comparator	Drug: Amitiza (Lubiprostone)106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Miralax plus Dulcolax	Active comparator	Drug: Dulcolax (Bisacodyl)107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Miralax	Active comparator	Drug: Miralax (PEG 3350)106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Golytely (polyethylene glycol)	Active comparator	Drug: Golytely (polyethylene glycol)106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy

Who may qualify

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

Key inclusion criteria (1 listed)

adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Key exclusion criteria (7 listed)

elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
previous diagnosis of congestive heart failure
history of bowel obstruction
history of solid organ transplant
current pregnancy

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
Miralax (PEG 3350)Miralax 255gm bottle	Drug	Miralax
Amitiza (Lubiprostone)Amitiza 24mcg gelcap	Drug	Miralax plus Amitiza
Dulcolax (Bisacodyl)Bisacodyl 5mg tab x2	Drug	Miralax plus Dulcolax
Golytely (polyethylene glycol)Golytely 1 gallon	Drug	Golytely (polyethylene glycol)

Primary outcome

The Cleanliness of the Prep as Measured by the Ottawa Scale
Time frame: measured at the time of colonoscopy
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.

3 secondary outcomes

Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
Time frame: measured at check in to colonoscopy
Procedure Time
Time frame: measured at the time of colonoscopy
Polyps Detected
Time frame: measured at the time of colonoscopy

Results and safety

Results posted to the registry on 30 Nov 2012, 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 Plus Amitiza	106	101
Miralax Plus Dulcolax	107	101
Miralax	106	100
Golytely (Polyethylene Glycol)	106	101

Primary outcome: The Cleanliness of the Prep as Measured by the Ottawa Scale

Time frame: measured at the time of colonoscopy. Mean (Full Range). Unit: Ottawa Scale

Measure	Miralax Plus Amitiza n = 101	Miralax Plus Dulcolax n = 101	Miralax n = 100	Golytely (Polyethylene Glycol) n = 101
Value	6.3 (4 to 12)	6.8 (4 to 13)	6.9 (4 to 13)	5.1 (3 to 10)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Miralax Plus Amitiza	0 of 101 (0%)	6 of 101 (5.9%)	Not reported
Miralax Plus Dulcolax	0 of 101 (0%)	4 of 101 (4%)	Not reported
Miralax	0 of 100 (0%)	6 of 100 (6%)	Not reported
Golytely (Polyethylene Glycol)	0 of 101 (0%)	7 of 101 (6.9%)	Not reported

Limitations and caveats (from the sponsor): Indication for colonoscopy was restricted to colorectal cancer screening. Patients admitted to the hospital were not included. Polyp detection rates could have been influenced by unequal randomization of high-risk and low-risk patients for adenomas.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21115134Hjelkrem M, Stengel J, Liu M, Jones DP, Harrison SA. MiraLAX is not as effective as GoLytely in bowel cleansing before screening colonoscopies. Clin Gastroenterol Hepatol. 2011 Apr;9(4):326-332.e1. doi: 10.1016/j.cgh.2010.11.007. Epub 2010 Nov 27.

Related trials for Colonoscopy

RecruitingObservational study
The French Gut-colo
Patients Aged 50-75 and Requiring Colonoscopy
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
Enrolling by invitation
The Effect of Virtual Reality Application on Pain, Anxiety, and Embarrassment During Colonoscopy
Colonoscopy
Recruiting
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Adenoma Detection Rate, Colonoscopy

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.

The record lists no contact. Use the official record to reach the sponsor.

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 (PEG 3350), Amitiza (Lubiprostone) and Dulcolax (Bisacodyl) in people with Colonoscopy, run by Brooke Army 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 7 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 30 Nov 2012. 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 30 Nov 2012). 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 Cleanliness of the Prep as Measured by the Ottawa Scale (time frame: measured at the time of 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 NCT00953017, 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 30 Nov 2012; AzTrials last refreshed its copy on 31 Oct 2026.