Bowel PreparationPhase 2NCT02402270
Safety and Tolerability Study of an Edible Colon Preparation
A Phase 2 study testing NuLYTELY® (PEG 3350), ECP-019 and MoviPrep® (PEG 3350) in people with Bowel Preparation, run by ColonaryConcepts LLC at 2 sites in United States.
Trial summary
The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon. In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- NuLYTELY® (PEG 3350), ECP-019 and MoviPrep® (PEG 3350)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Jun 2016
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
- Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.
Who cannot join
- Known intestinal stricture of any etiology.
- History of diabetes mellitus.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Indianapolis, Indiana, 46290
Study site
Lebanon, New Hampshire, 03756
About this study
Official title: An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.
The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.
In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.
Patients will be randomized (like flipping a coin) to one of five groups:
Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY
Read the detailed description
The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.
- Conditions
- Bowel Preparation
- Being tested
- NuLYTELY® (PEG 3350), ECP-019, MoviPrep® (PEG 3350)
- Keywords
- Colonoscopy, Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuLYTELY® (PEG 3350)Drug
ECP-019Drug
MoviPrep® (PEG 3350)Drug
| Study group | Role | What they receive |
|---|---|---|
| ECP-019 A (Group A) | Experimental | Not described Receives: Drug: ECP-019 |
| ECP-019 B (Group B) | Experimental | Not described Receives: Drug: ECP-019 |
| ECP-019 C (Group C) | Experimental | Not described Receives: Drug: ECP-019 |
| Group D | Active comparator | Not described Receives: Drug: MoviPrep® (PEG 3350) |
| Group E | Active comparator | Not described Receives: Drug: NuLYTELY® (PEG 3350) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
Measured: One year
Secondary outcomes (1)
Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- ColonaryConcepts LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402270
- Sponsor's protocol ID
- ECP-002
- Status last verified
- Jan 2018
- First submitted
- 25 Mar 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.
- ClinicalTrials.gov ID
- NCT02402270
- Acronym / sponsor ID
- ECP-002
- Conditions
- Bowel Preparation
- Keywords
- Colonoscopy, Preparation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- ColonaryConcepts LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Mar 2015 (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.
The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.
In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.
Patients will be randomized (like flipping a coin) to one of five groups:
Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY
Detailed description
The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ECP-019 A (Group A) | Experimental | Drug: ECP-019 |
| ECP-019 B (Group B) | Experimental | Drug: ECP-019 |
| ECP-019 C (Group C) | Experimental | Drug: ECP-019 |
| Group D | Active comparator | Drug: MoviPrep® (PEG 3350) |
| Group E | Active comparator | Drug: NuLYTELY® (PEG 3350) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
- Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.
Key exclusion criteria (2 listed)
- Known intestinal stricture of any etiology.
- History of diabetes mellitus.
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 |
|---|---|---|
| NuLYTELY® (PEG 3350) | Drug | Group E |
| ECP-019 | Drug | ECP-019 A (Group A), ECP-019 B (Group B), ECP-019 C (Group C) |
| MoviPrep® (PEG 3350) | Drug | Group D |
Primary outcome
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
Time frame: One year
1 secondary outcome
Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
Time frame: One year
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 29 Jan 2018.
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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.
2 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 NuLYTELY® (PEG 3350), ECP-019 and MoviPrep® (PEG 3350) in people with Bowel Preparation, run by ColonaryConcepts LLC at 2 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 2 inclusion and 2 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. (time frame: One year). 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 29 Jan 2018.