Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy

NCT03008460 | Completed Phase 3 Results

• 2 other identifiers: F-FR-58800-0032016-002265-60
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 24

Brief Summary

The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight \>40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.

Conditions

Digestive System Disease

Keywords

Bowel preparation

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale)

  Blinded overall assessment of preparation efficacy (Cleansing Score) was determined by the colonoscopist upon completion of the examination, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. Only perfect preparations graded as excellent (4) or good (3), which allowed full, reliable examination of the mucosa were considered as successful. The adjusted percentage of subjects with a successful preparation was determined using a logistic regression model, including treatment and country as covariates.

  At Day 2 (colonoscopy visit)

Secondary Outcomes (10)

• Mean Colon Cleansing Score (4-point Scale)

  At Day 2 (colonoscopy visit)

• Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment

  At Day 2 (colonoscopy visit)

• Percentage of Subjects With Need for Rescue Treatment

  At Day 2 (colonoscopy visit, before colonoscopy)

• Percentage of Subjects With Need for Nasogastric Tube To Complete Preparation

  At Day 1 (treatment visit)

• Percentage of Subjects With Colonoscopy Procedure Documented as Completed

  At Day 2 (colonoscopy visit)

Other Outcomes (2)

• Median Time to Clear Effluent

  From first intake of prescription to first clear watery stool, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)

• Mean Time Between Last Intake of Fluids and Start of Colonoscopy Procedure

  From end of treatment administration to start of colonoscopy, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)

Study Arms (2)

Eziclen®/Izinova®

EXPERIMENTAL

Drug: Eziclen®/Izinova®

Klean-Prep®

ACTIVE COMPARATOR

Drug: Klean-Prep®

Interventions

Eziclen®/Izinova® DRUG

Oral solution taken the evening before the colonoscopy

Also known as: Suprep®

Eziclen®/Izinova®

Klean-Prep® DRUG

Oral solution taken the evening before the colonoscopy

Klean-Prep®

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Provision of signed informed consent form to participate in the study obtained from the adolescent's parent(s)/ legal representative and a signed assent form from the adolescent according to local law
• Male or female subjects between 12 to 17 years of age (inclusive)
• Body weight more than 40 kg
• Female of childbearing potential must have a negative pregnancy test
• If female, and of child-bearing potential, subject must use an acceptable form of birth control (hormonal birth control, intrauterine device (IUD), double-barrier method, or depot contraceptive)
• Routinely accepted indication for undergoing colonoscopy, including but not limited to polyposis coli diagnosis or surveillance, gastrointestinal bleeding, unexplained diarrhoea or constipation, surveillance of inflammatory bowel disease or confirmation of mucosal healing, abdominal pain, abnormal endosonography or manometry, anaemia of unknown aetiology, cancer surveillance
• In the investigator's judgment, the parent(s)/legal representative are/is mentally competent to provide informed consent for the subject to participate in the study
• In the investigator's judgement, subject is able and willing to follow study procedures including drug administration and response to questionnaires

You may not qualify if:

• Subject with known or suspected ileus, gastrointestinal obstruction, gastric retention (gastroparesis), rectal impaction, toxic colitis, severe ulcerative colitis or toxic megacolon, advanced carcinoma, swallowing disorders
• Subject with known or suspected inflammatory bowel disease (Crohn's disease, ulcerative colitis) in moderate to severe active phase defined by Paediatric Crohn's Disease Activity Index (PCDAI) \>30 or Paediatric Ulcerative Colitis Index (PUCAI) \>34
• Subject with bowel perforation or increased risk of bowel perforation, including connective tissue disorders or recent bowel surgery
• Subject with previous significant gastrointestinal surgery (e.g. colostomy, colectomy, gastric bypass, stomach stapling)
• Subject with uncontrolled pre-existing electrolyte abnormalities, or with electrolyte abnormalities based on Visit 1 laboratory results such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalaemia, hypocalcaemia, uncorrected dehydration, or secondary to the use of medications such as diuretics or angiotensin converting enzyme inhibitors judged clinically significant by the investigator
• Subject with a prior history or current condition of severe renal (estimated glomerular filtration rate (GFR) less than 30 mL/min/1.73 m\^2 as calculated by using the Schwartz bedside equation\* \[Schwartz et al, 2009\]\*\*), liver (ascites, Child-Pugh C), cardiac insufficiency (including congestive heart failure all grades) or hyperuricemia
• \*The estimated GFR will be calculated in patients with elevated creatinine at baseline
• \*\*Schwartz GJ and Work DF. Measurement and Estimation of GFR in Children and Adolescents. Clin J Am Soc Nephrol. 2009; 4: 1832-1843
• Female subject who is pregnant or lactating
• Subject who has participated in another investigational drug treatment within the last 90 days before the first study visit
• Subject with phenylketonuria
• Subject with history of asthma or hypersensitivity to any ingredient of either drug product
• Subject for whom intake of substances likely to affect gastrointestinal motility or urinary flow rate is required
• Subject with requirement to take any other oral medication within 3 hours of starting the bowel preparation, as this may impact medication absorption
• Subject with tendency for nausea and/or vomiting

Sponsors & Collaborators

• Ipsen: lead

Study Sites (24)

Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia

Location

Université de Picardie Jules Verne

Amiens, 80054, France

Location

Hôpital Femme Mère-Enfant

Bron, 69677, France

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Uniklinikum Essen

Essen, 45147, Germany

Location

Evang Krankenhaus Hamm

Hamm, 59063, Germany

Location

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

Leipzig, 04103, Germany

Location

Klinikum Ulm

Ulm, 89075, Germany

Location

HELIOS Klinikum Wuppertal

Wuppertal, 42283, Germany

Location

ORN Santobono-Pausilipon Padiglione Santobono

Napoli, 680 122, Italy

Location

Ospedale "Spirito Santo" U.D.C.

Pescara, 65125, Italy

Location

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189, Italy

Location

AMC Emma kinderziekenhuis

Amsterdam, 1105 AZ, Netherlands

Location

Maasstad ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Copernicus Podmiot Leczniczy Sp. z.o.o

Gdansk, 80-803, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego

Katowice, 40-752, Poland

Location

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, 30-663, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

Lublin, 20-093, Poland

Location

Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, 20-093, Poland

Location

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, 04-730, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

Wroclaw, 50-369, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Zabrze, 41-800, Poland

Location

Related Publications (1)

• Socha P, Posovszky C, Szychta M, Viscogliosi F, Martemucci L, Grzybowska-Chlebowczyk U, Perrot V, Kornowski A, Benninga MA; EASYKID Study Group. Phase III Randomized Non-Inferiority Study of OSS Versus PEG + Electrolyte Colonoscopy Preparation in Adolescents. J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):652-659. doi: 10.1097/MPG.0000000000003745. Epub 2023 Feb 22.

  PMID: 36821851 DERIVED

MeSH Terms

Conditions

Digestive System Diseases

Interventions

klean prep

Results Point of Contact

• Title: Ipsen Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

use email

Study Officials

• Ipsen Medical Director

  Ipsen Consumer Healthcare

  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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 2, 2017
• Study Start: October 15, 2017
• Primary Completion: February 24, 2020
• Study Completion: June 29, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-03

Locations

DE (5); PL (9); CZ (2); NL (2); FR (3); IT (3)