Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 6821 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03008460
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Digestive System Disease Drug: Eziclen®/Izinova® Drug: Klean-Prep® Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Suprep

Arm Intervention/treatment
Experimental: Eziclen®/Izinova® Drug: Eziclen®/Izinova®
Oral solution taken the evening before the colonoscopy
Other Name: Suprep®

Active Comparator: Klean-Prep® Drug: Klean-Prep®
Oral solution taken the evening before the colonoscopy




Primary Outcome Measures :
  1. Blinded overall assessment of preparation efficacy (Cleansing Score) success as determined by the colonoscopist upon completion of the examination, based on a 4-point scale (4 - Excellent, 3 - Good, 2 - Fair, 1 - Poor). [ Time Frame: Day 2 ]
    Only perfect preparations graded as excellent (4) or good (3), which allow full, reliable examination of the mucosa, will be considered as successful.


Secondary Outcome Measures :
  1. Number (%) of subjects who need a nasogastric tube to complete preparation [ Time Frame: Day 1 ]
  2. Time to clear effluent measured as time between first intake of prescription and first clear watery stool, as reported by the subject [ Time Frame: Day 1 ]
  3. Number (%) of procedures that need a rescue treatment (saline enema) [ Time Frame: Day 2 ]
  4. Cleansing Scores assessed by the 4-point scale (poor, fair, good, excellent) [ Time Frame: Day 2 ]
  5. Overall and segmental Cleansing Scores assessed by Boston Bowel Preparation Scale (BBPS) [ Time Frame: Day 2 ]
  6. Duration of intubation (from colonoscope introduction to caecal intubation) [ Time Frame: Day 2 ]
  7. Duration of examination, measured by colonoscope withdrawal time from caecum [ Time Frame: Day 2 ]
  8. Number (%) of complete procedures defined as procedures that reached the caecum [ Time Frame: Day 2 ]
  9. Treatment compliance: volumes of fluid not taken by the subject measured by the caregiver and reported in the treatment questionnaire [ Time Frame: Day 1 ]
  10. Treatment acceptability, assessed by using a 5-point Treatment Acceptability Questionnaire [ Time Frame: Day 1 ]
  11. Collection of Adverse Events (for up to 30 days following the day of colonoscopy) [ Time Frame: From day 2 to day 32 (up to 30 days following colonoscopy) ]
  12. Tolerability assessed by a Symptom Scale after each dose of treatment. [ Time Frame: Day 1 ]
    Subjects will rate their preparation related symptoms after intake (stomach cramping, stomach bloating and nausea) on a paediatric 5-point scale, ranging from 1=no symptoms to 5=severely distressing symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed informed consent form (ICF) 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
  • Routinely accepted indication for undergoing colonoscopy

Exclusion Criteria:

  • 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 (ACE) 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 m2), liver (ascites, Child-Pugh C) or cardiac insufficiency (including congestive heart failure all grade) or hyperuricemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008460


Contacts
Layout table for location contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Layout table for location information
Czechia
Fakultní nemocnice Královské Vinohrady Recruiting
Praha, Czechia, 100 34
Všeobecná fakultní nemocnice v Praze Recruiting
Praha, Czechia, 128 08
France
Université de Picardie Jules Verne Recruiting
Amiens, France, 80054
Hôpital Femme Mère-Enfant Recruiting
Bron, France, 69677
Hôpital Necker Enfants Malades Recruiting
Paris, France, 75015
Germany
Uniklinikum Essen Recruiting
Essen, Germany, 45147
Evang Krankenhaus Hamm Recruiting
Hamm, Germany, 59063
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin Recruiting
Leipzig, Germany, 04103
Klinikum Ulm Recruiting
Ulm, Germany, 89075
HELIOS Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Italy
ORN Santobono-Pausilipon Padiglione Santobono Recruiting
Napoli, Italy, 680 122
Ospedale "Spirito Santo" U.D.C. Recruiting
Pescara, Italy, 65125
Azienda Ospedaliero-Universitaria Sant'Andrea Not yet recruiting
Roma, Italy, 00189
Netherlands
Noord West Ziekenhuisgroep Withdrawn
Alkmaar, Netherlands, 1814 HB
AMC Emma kinderziekenhuis Recruiting
Amsterdam, Netherlands, 1105 AZ
Maasstad ziekenhuis Recruiting
Rotterdam, Netherlands, 3079 DZ
Maxima Medisch Centrum Withdrawn
Veldhoven, Netherlands, 5504 DB
Poland
Copernicus Podmiot Leczniczy Sp. z.o.o Recruiting
Gdańsk, Poland, 80-803
Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego Recruiting
Katowice, Poland, 40-752
Uniwersytecki Szpital Dziecięcy w Krakowie Recruiting
Kraków, Poland, 30-663
Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku Recruiting
Lublin, Poland, 20-093
Uniwersytecki Szpital Dziecięcy w Lublinie Recruiting
Lublin, Poland, 20-093
Instytut "Pomnik - Centrum Zdrowia Dziecka" Recruiting
Warszawa, Poland, 04-730
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu Recruiting
Wrocław, Poland, 50-369
Samodzielny Publiczny Szpital Kliniczny Nr 1 Recruiting
Zabrze, Poland, 41-800
Instytut Centrum Zdrowia Matki Polki Recruiting
Łódź, Poland, 93-338
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen

Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03008460     History of Changes
Other Study ID Numbers: F-FR-58800-003
2016-002265-60 ( EudraCT Number )
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Diseases
Digestive System Diseases