EUCTR2016-002265-60-PL
Active, not recruiting
Phase 1
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.P/214/2011 - EASYKID
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ipsen Pharma
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject MUST satisfy all of the following entry criteria before being allowed to participate in the study:
- •(1\) 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
- •(2\) Male or female subjects between 12 to 17 years of age (inclusive)
- •(3\) Body weight more than 40 kg
- •(4\) Female of childbearing potential must have a negative pregnancy test
- •(5\) 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)
- •(6\) 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
- •(7\) 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
- •(8\) In the investigator’s judgement, subject is able and willing to follow study procedures including drug administration and response to questionnaires
- •Are the trial subjects under 18? yes
Exclusion Criteria
- •If any of the following apply, the subject MUST NOT enter/continue in the study:
- •(1\) 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
- •(2\) Subject with known or suspected inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in moderate to severe active phase defined by PCDAI \>30 (Crohn’s disease) or PUCAI \>34 (ulcerative colitis)
- •(3\) Subject with bowel perforation or increased risk of bowel perforation, including connective tissue disorders or recent bowel surgery
- •(4\) Subject with previous significant gastrointestinal surgery (e.g. colostomy, colectomy, gastric bypass, stomach stapling)
- •(5\) 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
- •(6\) Subject with a prior history or current condition of severe renal (estimated glomerular filtration rate (eGFR) less than 30 mL/min/1\.73 m2 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
- •(7\) Female subject who is pregnant or lactating
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
COMPARAISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN®/IZINOVA® VERSUS KLEAN-PREP® ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS > 40 KG UNDERGOING COLONOSCOPY.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 surveillanceMedDRA version: 21.0Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2016-002265-60-DEIpsen Pharma250
Active, not recruiting
Phase 1
COMPARAISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN®/IZINOVA® VERSUS KLEAN-PREP® ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS =40 KG UNDERGOING COLONOSCOPY.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 surveillanceMedDRA version: 19.1Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2016-002265-60-FRIpsen Pharma250
Active, not recruiting
Phase 1
COMPARISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN®/IZINOVA® VERSUS KLEAN-PREP® ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS >40 KG UNDERGOING COLONOSCOPY.EUCTR2016-002265-60-NLIpsen Pharma250
Active, not recruiting
Phase 1
COMPARAISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN¿/IZINOVA¿ VERSUS KLEAN-PREP¿ ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS >40 KG UNDERGOING COLONOSCOPY.EUCTR2016-002265-60-ITIPSEN PHARMA SAS250
Active, not recruiting
Phase 1
COMPARAISON OF THE EFFICACY, SAFETY AND TOLERABILITY OF EZICLEN®/IZINOVA® VERSUS KLEAN-PREP® ON BOWEL CLEANSING IN ADOLESCENTS AGED 12-17 YEARS >40 KG UNDERGOING COLONOSCOPY.EUCTR2016-002265-60-CZIpsen Pharma250