MedDataX Logo

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

NCT ID: NCT00953017

Last Updated: 2012-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Efficacy of bowel cleansing Patient tolerability Amitiza Dulcolax Miralax Colonoscopy preparation Bowel preparation Screening colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Miralax plus Amitiza

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.

Group Type ACTIVE_COMPARATOR

Amitiza (Lubiprostone)

Intervention Type DRUG

Amitiza 24mcg gelcap

Miralax plus Dulcolax

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.

Group Type ACTIVE_COMPARATOR

Dulcolax (Bisacodyl)

Intervention Type DRUG

Bisacodyl 5mg tab x2

Miralax

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.

Group Type ACTIVE_COMPARATOR

Miralax (PEG 3350)

Intervention Type DRUG

Miralax 255gm bottle

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

Group Type ACTIVE_COMPARATOR

Golytely (polyethylene glycol)

Intervention Type DRUG

Golytely 1 gallon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Miralax (PEG 3350)

Miralax 255gm bottle

Intervention Type DRUG

Amitiza (Lubiprostone)

Amitiza 24mcg gelcap

Intervention Type DRUG

Dulcolax (Bisacodyl)

Bisacodyl 5mg tab x2

Intervention Type DRUG

Golytely (polyethylene glycol)

Golytely 1 gallon

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joel Z. Stengel

Gastroenterology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brooke Army Medical Center

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21115134 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C.2009.209

Identifier Type: -

Identifier Source: org_study_id