Screening ColonoscopyNCT01838408
Evaluation of Proposed EZ2go Complete Bowel Cleansing System
A study testing Ez2go Complete and LoSo Prep in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Borland-Groover Clinic at 1 site in United States.
Trial summary
This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy, Surveillance Colonoscopy, Colonoscopy
- What is being tested?
- Ez2go Complete and LoSo Prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
- Male and Female participants 18 years of age and older.
- Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
- Negative urine test at the screening visit.
- Subject is able to read and understand the informed consent form and signs the informed consent form.
Who cannot join
- Contraindication to any of the bowel preparations being used in the study.
- Unable/unwilling to fill out patient questionnaires following procedure.
- Pregnant or lactating.
- Unwilling to perform indicated lab work.
- Lab results that would indicate stage 4-5 chronic kidney disease (GFR <30MI/min1.73 m2).
- Personal history of colorectal cancer.
- Personal history of colorectal or small bowel surgery.
- Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation
This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).
To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.
- Conditions
- Screening Colonoscopy, Surveillance Colonoscopy, Colonoscopy
- Being tested
- Ez2go Complete, LoSo Prep
- Keywords
- screening colonoscopy, surveillance colonoscopy, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ez2go CompleteOther
EZ2Go Complete
LoSo PrepOther
LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm
| Study group | Role | What they receive |
|---|---|---|
| EZ2go Complete | Experimental | EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone Receives: Other: Ez2go Complete |
| LoSo Prep ™ | Active comparator | LoSo Prep ™: Magnesium citrate and Bisacodyl Receives: Other: LoSo Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Efficacy
The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.
Measured: 24 hours
Secondary outcomes (1)
Evaluate the safety
A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Borland-Groover Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Valley Medical Products, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838408
- Sponsor's protocol ID
- Pro00008184
- Status last verified
- Jan 2015
- First submitted
- 16 Apr 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation
- ClinicalTrials.gov ID
- NCT01838408
- Acronym / sponsor ID
- Pro00008184
- Conditions
- Screening Colonoscopy, Surveillance Colonoscopy, Colonoscopy
- Keywords
- screening colonoscopy, surveillance colonoscopy, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Borland-Groover ClinicUniversity, hospital or other
- Collaborators
- Valley Medical Products, LLC
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Apr 2013 (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.
This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).
To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EZ2go Complete | Experimental | Other: Ez2go CompleteEZ2go complete: Peg 3350, Magnesium Citrate and Simethicone |
| LoSo Prep ™ | Active comparator | Other: LoSo PrepLoSo Prep ™: Magnesium citrate and Bisacodyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
- Male and Female participants 18 years of age and older.
- Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
- Negative urine test at the screening visit.
- Subject is able to read and understand the informed consent form and signs the informed consent form.
Key exclusion criteria (8 listed)
- Contraindication to any of the bowel preparations being used in the study.
- Unable/unwilling to fill out patient questionnaires following procedure.
- Pregnant or lactating.
- Unwilling to perform indicated lab work.
- Lab results that would indicate stage 4-5 chronic kidney disease (GFR <30MI/min1.73 m2).
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 |
|---|---|---|
| Ez2go CompleteEZ2Go Complete | Other | EZ2go Complete |
| LoSo PrepLoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm | Other | LoSo Prep ™ |
Primary outcome
Measurement of Efficacy
Time frame: 24 hours
The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.
1 secondary outcome
Evaluate the safety
Time frame: 2 weeks
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 27 Jan 2015.
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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.
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 study testing Ez2go Complete and LoSo Prep in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Borland-Groover Clinic 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 5 inclusion and 8 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 27 Jan 2015. 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.
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?
Measurement of Efficacy (time frame: 24 hours). 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 27 Jan 2015.