NL-OMON49151
Completed
Phase 3
Efficacy, safety and tolerability of a bowel cleansing preparation (Eziclen®/Izinova®)<br>in paediatric subjects undergoing colonoscopy: a Phase III, multicentre, randomised, comparative study versus Klean-Prep® (PEG-Electrolytes), administered on the day before colonoscopy,<br>Investigator-blinded, non-inferiority in adolescents of 12 to 17 years of age (inclusive) > 40 kg.<br> - EASYKID
Ipsen Pharmaceuticals0 sites65 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ipsen Pharmaceuticals
- Enrollment
- 65
- Status
- Completed
- Last Updated
- 2 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),
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,
Outcomes
Primary Outcomes
Not specified
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