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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02321462 |
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Date of registration:
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17/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy
ESTOS |
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Scientific title:
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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 |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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296 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02321462 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Ipsen Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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:
1. Routine cancer screening
2. Polyp or neoplasm history
3. Diagnostic procedure for occult bleeding or anaemia
4. Diarrhoea or constipation of unknown aetiology
5. IBD if not in severe acute phase
6. Abnormal ultrasound exam (i.e. mass in abdomen)
7. 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)
Exclusion Criteria:
- 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.
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bowel Cleansing
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Intervention(s)
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Drug: Fortrans®
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Drug: Eziclen
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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The Percentage of Patients for Whom the Colonoscopy Was Completed
[Time Frame: Colonoscopy was performed on Day 2.]
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Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
[Time Frame: Colonoscopy was performed on Day 2.]
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Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
[Time Frame: Colonoscopy was performed on Day 2.]
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Mean Colonoscopy Duration
[Time Frame: Colonoscopy was performed on Day 2.]
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Mean BBPS Score by Segment and Globally (ITT Population)
[Time Frame: Colonoscopy was performed on Day 2.]
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The Percentage of Patients in Whom Lesions Were Detected.
[Time Frame: Colonoscopy was performed on Day 2.]
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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.]
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Secondary ID(s)
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A-38-58800-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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