Bowel CleansingPhase 3ESTOSNCT02321462
Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy
A Phase 3 study testing Eziclen and Fortrans® in people with Bowel Cleansing, run by Ipsen at 3 sites in Russia.
Trial summary
The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing
- What is being tested?
- Eziclen and Fortrans®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 3 sitesRussia
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent signed prior to any study related procedures
- Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication:
- Routine cancer screening
- Polyp or neoplasm history
- Diagnostic procedure for occult bleeding or anaemia
- Diarrhoea or constipation of unknown aetiology
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- IBD if not in severe acute phase
- Abnormal ultrasound exam (i.e. mass in abdomen)
- Evaluation of barium enema or computed tomography (CT) scan results
- In good clinical condition (physical exam and medical history)
- Subjects with an adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, bicarbonate within normal/near normal range)
Who cannot join
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Has an advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
- Has a known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
- Has a known or suspected ileus.
- Has a bowel perforation.
- Has profuse vomiting.
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- Needs a therapeutic procedure (e.g. polypectomy, mucosectomy).
- Has toxic colitis or megacolon.
- Is in severe acute phases of active IBD, as a contraindication for colonoscopy.
- Has acute GI bleeding.
- Underwent previous GI surgeries (e.g. colostomy, colectomy, gastric bypass, stomach stapling).
- Has impaired consciousness predisposing to pulmonary aspiration.
- Needs a colonoscopy for foreign body removal and decompression.
- Underwent previous incomplete colonoscopy.
- Has a known severe renal insufficiency (glomerular filtration rate (GFR) <30 mL/min/1.73 m2).
- Has a known severe liver insufficiency (Child-Pugh grade C: 10 to 15 points).
- Suffers from uncorrected dehydration.
- Has ascites.
- Suffers from severe congestive heart failure (classes III and IV).
- Has hyperuricemia with clinical manifestation as gouty arthritis.
- Is pregnant or lactating.
- Is a female at risk of pregnancy and not using an acceptable contraceptive method during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), or injectable contraception or an intra-uterine device. Nonchildbearing potential is defined as postmenopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- Has any known hypersensitivity to the active substances or to any of the preparation excipients (Eziclen or Fortrans®: polyethylene glycol (PEG) (macrogol), sodium sulphate, potassium sulphate, magnesium sulphate, sodium chloride, potassium chloride, sodium bicarbonate, sucralose, sodium saccharin, sodium benzoate, citric acid, malic acid, and fruit cocktail flavor).
- Patient has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
- Patient was treated with any other IMP within the last 30 days before study entry
- Patient is likely to require treatment during the study with drugs that are not permitted by the study protocol
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State Healthcare Institution Municipal Clinical Hospital No. 31 of Moscow
Moscow, 119415
Federal State Budgetary Institution "State Scientifical Center of Coloproctology"
Moscow, 123423
State Healthcare Institution of Yaroslavl Region "Regional Clinical Cancer Hospital"
Yaroslavl, 150054
About this study
Official title: Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (Eziclen) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, Randomised, 2 Parallel Group, Comparative Versus Fortrans®, Non-inferiority, Investigator-blinded Study
The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
- Conditions
- Bowel Cleansing
- Being tested
- Eziclen, Fortrans®
- Keywords
- preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EziclenDrug
Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy.
Fortrans®Drug
Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Eziclen | Experimental | Not described Receives: Drug: Eziclen |
| Fortrans® | Active comparator | Not described Receives: Drug: Fortrans® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid.
A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments.
The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (<= 65; > 65), gender and inflammatory bowel disease (IBD) status.
Measured: Colonoscopy was performed on Day 2.
Secondary outcomes (7)
Mean BBPS Score by Segment and Globally (ITT Population)
The mean global BBPS scores and scores by colon segment are presented for the ITT population.
For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts:
- unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0
- portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1
- minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2
- entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3.
The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately.
Measured: Colonoscopy was performed on Day 2.
Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented.
For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows:
- unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0
- portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1
- minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2
- entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3.
Reconciled scores were based on the 3 blinded reviews.
Measured: Colonoscopy was performed on Day 2.
The Percentage of Patients in Whom Lesions Were Detected.
The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented.
Measured: Colonoscopy was performed on Day 2.
The Percentage of Patients for Whom the Colonoscopy Was Completed
The percentage of patients for whom a total colonoscopy could be completed is presented.
Measured: Colonoscopy was performed on Day 2.
Mean Colonoscopy Duration
The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes.
Measured: Colonoscopy was performed on Day 2.
Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator.
The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows:
- presence of faeces and soiled fluid: investigation could not be reliably performed = 0
- presence of faecal material and of unclear fluid, with negative effect on the reliability of the investigation = 1
- brown liquid, no solid faecal material, presence of unclear residual fluid that could be aspirated: no effect on the reliability of the investigation = 2
- absence of solid faecal material, presence of clear residual fluid = 3
- no faecal material, no residual fluid, empty colon = 4.
Measured: Colonoscopy was performed on Day 2.
Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment
Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment.
A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented.
Measured: Study treatment was administered as a split-dose on Days 1 and 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bowel CleansingStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321462
- Sponsor's protocol ID
- A-38-58800-002
- Acronym
- ESTOS
- Status last verified
- Mar 2019
- First submitted
- 17 Dec 2014
- Last updated
- 4 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (Eziclen) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, Randomised, 2 Parallel Group, Comparative Versus Fortrans®, Non-inferiority, Investigator-blinded Study
- ClinicalTrials.gov ID
- NCT02321462
- Acronym / sponsor ID
- ESTOS / A-38-58800-002
- Conditions
- Bowel Cleansing
- Keywords
- preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Posted 27 Feb 2019
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 demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eziclen | Experimental | Drug: Eziclen |
| Fortrans® | Active comparator | Drug: Fortrans® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of written informed consent signed prior to any study related procedures
- Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication:
- In good clinical condition (physical exam and medical history)
- Subjects with an adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, bicarbonate within normal/near normal range)
Key exclusion criteria (26 listed)
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- Has an advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
- Has a known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
- Has a known or suspected ileus.
- Has a bowel perforation.
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 |
|---|---|---|
| EziclenEziclen solution administered orally as split-dose the day before and on the day of colonoscopy. | Drug | Eziclen |
| Fortrans®Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy. | Drug | Fortrans® |
Primary outcome
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
Time frame: Colonoscopy was performed on Day 2.
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (<= 65; > 65), gender and inflammatory bowel disease (IBD) status.
7 secondary outcomes
Mean BBPS Score by Segment and Globally (ITT Population)
Time frame: Colonoscopy was performed on Day 2.
Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
Time frame: Colonoscopy was performed on Day 2.
The Percentage of Patients in Whom Lesions Were Detected.
Time frame: Colonoscopy was performed on Day 2.
The Percentage of Patients for Whom the Colonoscopy Was Completed
Time frame: Colonoscopy was performed on Day 2.
Mean Colonoscopy Duration
Time frame: Colonoscopy was performed on Day 2.
Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
Time frame: Colonoscopy was performed on Day 2.
Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment
Time frame: Study treatment was administered as a split-dose on Days 1 and 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eziclen and Fortrans® in people with Bowel Cleansing, run by Ipsen at 3 sites in Russia.
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 11 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 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS). (time frame: Colonoscopy was performed on Day 2.). 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 4 Mar 2019.