Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy

NCT02321462 | Completed Phase 3 Results

• 1 other identifier: A-38-58800-002
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 3

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.

Conditions

Bowel Cleansing

Keywords

preparation

Outcome Measures

Primary Outcomes (1)

• 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.

  Colonoscopy was performed on Day 2.

Secondary Outcomes (7)

• Mean BBPS Score by Segment and Globally (ITT Population)

  Colonoscopy was performed on Day 2.

• Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)

  Colonoscopy was performed on Day 2.

• The Percentage of Patients in Whom Lesions Were Detected.

  Colonoscopy was performed on Day 2.

• The Percentage of Patients for Whom the Colonoscopy Was Completed

  Colonoscopy was performed on Day 2.

• Mean Colonoscopy Duration

  Colonoscopy was performed on Day 2.

Study Arms (2)

Eziclen

EXPERIMENTAL

Drug: Eziclen

Fortrans®

ACTIVE COMPARATOR

Drug: Fortrans®

Interventions

Eziclen DRUG

Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy.

Eziclen

Fortrans® DRUG

Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.

Fortrans®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ipsen: lead

Study Sites (3)

State Healthcare Institution Municipal Clinical Hospital No. 31 of Moscow

Moscow, 119415, Russia

Location

Federal State Budgetary Institution "State Scientifical Center of Coloproctology"

Moscow, 123423, Russia

Location

State Healthcare Institution of Yaroslavl Region "Regional Clinical Cancer Hospital"

Yaroslavl, 150054, Russia

Location

Limitations and Caveats

The differences in the Safety and ITT populations were due to 3 drug administration deviations. 2 patients initially randomized in the Fortrans® group received Eziclen and 1 patient initially randomized in the Eziclen group received Fortrans® .

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen Pharma

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 4, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-03

Locations

RU (3)