ColonoscopyPhase 4LUSTERNCT00779649
MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial
A Phase 4 study testing MoviPrep Kit and HalfLytely and Bisacodyl Tablets Bowel Prep Kit in people with Colonoscopy, run by Research Associates of New York, LLP.
Trial summary
A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- MoviPrep Kit and HalfLytely and Bisacodyl Tablets Bowel Prep Kit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has provided written informed consent.
- Is scheduled for colonoscopy within 30 days of screening
- Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
- Is able to communicate effectively with study personnel.
Who cannot join
- Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
- Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
- History of renal insufficiency
About this study
Official title: MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.
A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.
Read the detailed description
To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing colonoscopy
- Conditions
- Colonoscopy
- Being tested
- MoviPrep Kit, HalfLytely and Bisacodyl Tablets Bowel Prep Kit
- Keywords
- Colonoscopy,, Prep, MoviPrep, HalfLytely, The effectiveness of colonoscopy preps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoviPrep KitOther
Diet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure.
Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption.
HalfLytely and Bisacodyl Tablets Bowel Prep KitOther
Diet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed.
Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed
| Study group | Role | What they receive |
|---|---|---|
| MoviPrep | Active comparator | Not described Receives: Other: MoviPrep Kit |
| HalfLytely | Active comparator | Not described Receives: Other: HalfLytely and Bisacodyl Tablets Bowel Prep Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire.
Measured: one year from the trial start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Associates of New York, LLP
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence B Cohen, MD, Principal investigator, New York Gastroenterology Associates, L.L.P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779649
- Sponsor's protocol ID
- LUSTER
- Acronym
- LUSTER
- Status last verified
- Oct 2009
- First submitted
- 22 Oct 2008
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MoviPrep® Versus HalfLytely® for Colon Cleansing: An Investigator-blinded, Randomized Trial.
- ClinicalTrials.gov ID
- NCT00779649
- Acronym / sponsor ID
- LUSTER / LUSTER
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy,, Prep, MoviPrep, HalfLytely, The effectiveness of colonoscopy preps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Research Associates of New York, LLPUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A properly prepared colon is vital to the success of any colonoscopy. The purpose of this study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping agent.
Detailed description
To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing colonoscopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoviPrep | Active comparator | Other: MoviPrep Kit |
| HalfLytely | Active comparator | Other: HalfLytely and Bisacodyl Tablets Bowel Prep Kit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has provided written informed consent.
- Is scheduled for colonoscopy within 30 days of screening
- Is a male or non-pregnant, non-lactating female, at least 18 years of age and not greater than 75 years of age. Females of childbearing potential must be using an acceptable form of birth control
- Is able to communicate effectively with study personnel.
Key exclusion criteria (3 listed)
- Known allergy or hypersensitivity to any constituent of MoviPrep® (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid), or any constituent of HalfLytely with bisacodyl (lactose (anhydrous), NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, eudragit L 30-55, talc USP, gelatin, calcium sulfate (anhydrous) NF, confections sugar, kaolin USP, sucrose NF, opalus pink, beeswax, carnuba wax, saccharine.
- Use of any drugs that may affect GI motility such as laxatives, stool softeners, promotility agents, products to prevent diarrhea, purgatives and enemas during the study. Non-systematically absorbed medications (e.g. milk of magnesia, MiralaxTM) can be held for 24 hours prior to taking the study medication. Systematically absorbed medications can be held based upon their half-life and length of activity.
- History of renal insufficiency
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 |
|---|---|---|
| MoviPrep KitDiet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure. Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption. | Other | MoviPrep |
| HalfLytely and Bisacodyl Tablets Bowel Prep KitDiet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed. Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed | Other | HalfLytely |
Primary outcome
The primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire.
Time frame: one year from the trial start date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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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.
Lawrence B Cohen, MD principal investigator
New York Gastroenterology Associates, L.L.P
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MoviPrep Kit and HalfLytely and Bisacodyl Tablets Bowel Prep Kit in people with Colonoscopy, run by Research Associates of New York, LLP.
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 4 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 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 primary endpoint of the study will be a comparison of mean overall colon cleansing scores for each treatment arm, determined by the ratings on the Physician Questionnaire. (time frame: one year from the trial start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2009.