Colon Prep for ColonoscopyPhase 2NCT03332485
Safety and Efficacy Study of an Edible Colonoscopy Preparation
A Phase 2 study testing ECP Colon Prep Kit and MoviPrep® in people with Colon Prep for Colonoscopy, run by Sebela Pharmaceuticals Development LLC at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Prep for Colonoscopy
- What is being tested?
- ECP Colon Prep Kit and MoviPrep®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Nov 2017to 14 Mar 2018
- Phase
- Phase 2
- 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
- Scheduled to undergo a medically indicated colonoscopy for colorectal cancer screening or surveillance for colorectal cancer
- Females must be non-lactating and have a negative pregnancy test if of child bearing potential
- Ability and willingness of subject to participate fully in all aspects of this clinical trial
- Written informed consent
Who cannot join
- Known or suspected clinically significant intestinal stricture of any etiology
- History of diabetes mellitus, controlled with insulin
- Taking insulin by injection
- Pregnant or lactating
- Renal insufficiency, hypokalemia, hyperkalemia, chronic liver disease or arrhythmic disorder
- Chronic heart failure or recent (within 90 days of screening) acute heart failure
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- Receiving warfarin, heparin, clopidogrel, Pradaxa®, Xarelto®, Effient® or other blood thinning agents
- Short bowel syndrome
- Known diagnosis of Crohn's disease or ulcerative colitis, exclusionary only if subject has a history of any bowel resection, has suspected active inflammation, has symptoms suggestive of obstruction or a known bowel stricture
- Severe psychological disease causing functional impairment limiting capacity to complete the preparation
- Impaired consciousness increasing the risk of aspiration
- Used narcotics/opiates within the 14 days prior to the colonoscopy
- Used an anti-diarrheal within the 14 days prior to the colonoscopy procedure
- Uses drugs of abuse including abused prescription medication
- Used iron supplements within 14 days of the colonoscopy procedure
- History of gastrointestinal surgery other than appendectomy or cholecystectomy
- Diagnosis of gastroparesis or ileus
- Symptoms of chronic constipation defined as fewer than 3 bowel movements per week on average over the previous 3 months
- History of a failed bowel preparation, defined as either requiring an enema the day of the colonoscopy or needing to have the colonoscopy repeated
- CTCAE grade 1 sodium, potassium or magnesium at screening
- Clinically significant abnormalities (ketones, protein, glucose) at screening urinalysis, in the opinion of the investigator
- Any known allergies to any of the ingredients or ECP Colon Prep Kit (including coconut) or the active comparator
- Unable or unwilling to consume all components of the study drug including aversions to or adverse events from flavoring
- Received any investigational therapy within 30 days of initiation of study drug
- Serious underlying disease that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
- Requirement to use chromoendoscopy during the procedure for the purpose of surveillance for colorectal dysplasia or cancer in subjects with inflammatory bowel disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Sebela Site 007
Anaheim, California, 92801
Sebela Site 003
Annapolis, Maryland, 21401
Sebela Site 002
Bastrop, Louisiana, 71220
Sebela Site 004
Great Neck, New York, 11023
Sebela Site 006
Indianapolis, Indiana, 46202
Sebela Site 001
Mentor, Ohio, 44060
Sebela Site 005
Ogden, Utah, 84405
Sebela Site 008
Wilmington, North Carolina, 28403
About this study
Official title: A Randomized, Investigator- and Colonoscopist-blinded, Phase 2 Study of the Efficacy and Safety of ECP (Polyethylene Glycol 3350 [PEG 3350]) Colon Prep Kit Compared With MoviPrep® Split-dose for Colonoscopy Preparation
The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.
- Conditions
- Colon Prep for Colonoscopy
- Being tested
- ECP Colon Prep Kit, MoviPrep®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECP Colon Prep KitDrug
ECP Colon Prep Kit
MoviPrep®Drug
MoviPrep®
| Study group | Role | What they receive |
|---|---|---|
| ECP Colon Prep Kit | Experimental | Not described Receives: Drug: ECP Colon Prep Kit |
| MoviPrep® | Active comparator | Not described Receives: Drug: MoviPrep® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with successful bowel cleansing defined as centrally read 4 point modified Aronchick Scale (1=Inadequate, 2=Fair, 3=Good, 4=Excellent) score of either good or excellent.
Measured: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start20 Nov 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Prep 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebela Pharmaceuticals Development LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sue Hall, Study director, Sebela Pharmaceuticals Development LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332485
- Sponsor's protocol ID
- SEB-ECP-202
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator- and Colonoscopist-blinded, Phase 2 Study of the Efficacy and Safety of ECP (Polyethylene Glycol 3350 [PEG 3350]) Colon Prep Kit Compared With MoviPrep® Split-dose for Colonoscopy Preparation
- ClinicalTrials.gov ID
- NCT03332485
- Acronym / sponsor ID
- SEB-ECP-202
- Conditions
- Colon Prep for Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sebela Pharmaceuticals Development LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
The purpose of this study is to evaluate the efficacy and safety of ECP (PEG 3350) Colon Prep Kit compared with MoviPrep split-dose as a colon-cleansing preparation for colonoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECP Colon Prep Kit | Experimental | Drug: ECP Colon Prep Kit |
| MoviPrep® | Active comparator | Drug: MoviPrep® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo a medically indicated colonoscopy for colorectal cancer screening or surveillance for colorectal cancer
- Females must be non-lactating and have a negative pregnancy test if of child bearing potential
- Ability and willingness of subject to participate fully in all aspects of this clinical trial
- Written informed consent
Key exclusion criteria (26 listed)
- Known or suspected clinically significant intestinal stricture of any etiology
- History of diabetes mellitus, controlled with insulin
- Taking insulin by injection
- Pregnant or lactating
- Renal insufficiency, hypokalemia, hyperkalemia, chronic liver disease or arrhythmic disorder
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 |
|---|---|---|
| ECP Colon Prep KitECP Colon Prep Kit | Drug | ECP Colon Prep Kit |
| MoviPrep®MoviPrep® | Drug | MoviPrep® |
Primary outcome
Proportion of subjects with successful bowel cleansing defined as centrally read 4 point modified Aronchick Scale (1=Inadequate, 2=Fair, 3=Good, 4=Excellent) score of either good or excellent.
Time frame: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.
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 19 Mar 2018.
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.
Sue Hall study director
Sebela Pharmaceuticals Development LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ECP Colon Prep Kit and MoviPrep® in people with Colon Prep for Colonoscopy, run by Sebela Pharmaceuticals Development LLC at 8 sites 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 4 inclusion and 26 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of subjects with successful bowel cleansing defined as centrally read 4 point modified Aronchick Scale (1=Inadequate, 2=Fair, 3=Good, 4=Excellent) score of either good or excellent. (time frame: 24-hour period, beginning the day prior to the procedure and through the morning of the colonoscopy procedure.). 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 19 Mar 2018.