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Which bowel preparation regime gives the most optimal Colon Capsule Endocscopy in patients with high risk polyps.

Phase 1
Conditions
Endoscopic examination of the colon and rectum for polyps and cancers
MedDRA version: 19.0Level: LLTClassification code 10010026Term: Colorectal cancer Duke's ASystem Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010027Term: Colorectal cancer Duke's CSystem Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010028Term: Colorectal cancer Duke's DSystem Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010024Term: Colorectal cancer Duke's B1System Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010025Term: Colorectal cancer Duke's B2System Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864
MedDRA version: 19.0Level: LLTClassification code 10010031Term: Colorectal cancer stage B2System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2016-002237-30-DK
Lead Sponsor
Odense University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
180
Inclusion Criteria

Patients in high risk of delopment of polyps in the colon or rectum because of previously presence of polyps larger than 10 mm and/or more than 3 polyps in one patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

Criteria for exclusion are:
- Hypersensitivity to the active substances or one or more of the subsidiary substances, including
o Phenylketonuri (due to aspartam in Moviprep®)
o Glucose-6-phosphate-dehydrogenase deficiency (due to ascorbate in Moviprep®)
- Gastrointestinal obstruction or perforation
- Previous problems with bowel cleansing
- Ileus
- Toxic megacolon, which complicates serious inflammatoric conditions in the intestinal canal including Morbus Crohn and colitis ulcerosa
- Serious (known) kidney disease
- Previous surgery/resection of colon or rectum (except for appendectomy)
- Pregnancy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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