Clinical trial NCT02321462: Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Cleansing
Keywords: preparation
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
timeFrame: Colonoscopy was performed on Day 2.
Secondary outcomes:
measure: Mean BBPS Score by Segment and Globally (ITT Population)
timeFrame: Colonoscopy was performed on Day 2.
measure: Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
timeFrame: Colonoscopy was performed on Day 2.
measure: The Percentage of Patients in Whom Lesions Were Detected.
timeFrame: Colonoscopy was performed on Day 2.
measure: The Percentage of Patients for Whom the Colonoscopy Was Completed
timeFrame: Colonoscopy was performed on Day 2.
measure: Mean Colonoscopy Duration
timeFrame: Colonoscopy was performed on Day 2.
measure: Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
timeFrame: Colonoscopy was performed on Day 2.
measure: Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment
timeFrame: Study treatment was administered as a split-dose on Days 1 and 2.
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Healthcare Institution Municipal Clinical Hospital No. 31 of Moscow
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "State Scientifical Center of Coloproctology"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Region "Regional Clinical Cancer Hospital"
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: