The effect of a new low volume bowel preparation versus a high volume bowel preparation, a randomized trial

Phase 1

• Conditions: Bowel preparation before colonoscopy; MedDRA version: 20.0Level: HLGTClassification code 10017971Term: Gastrointestinal investigationsSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.1Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2018-003304-39-DK
• Lead Sponsor: Morten Rasmussen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1274

Inclusion Criteria

Participants in the Danish national bowel cancer screening scheduled for colonoscopy at one of the two centres (Bispebjerg Hospital or Herlev Hospital
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 637
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 637

Exclusion Criteria

•Not able to understand, read or speak Danish
•Not able to receive documents sent via e-Boks
•Anticipated compliance problems
•Hypersensitivity to the active substances in Moviprep or Plenvu
•Gastrointestinal obstruction or perforation
•Disorders of gastric emptying
•Ileus
•Phenylketonuria
•Glucose-6-phosphate dehydrogenase deficiency
•Toxic megacolon
•Severe chronic inflammatory bowel disease
•Pregnancy
•Breastfeeding
•Severe kidney impairment (creatinine clearance less than 30 ml/minute/1.73 m2
•Cardiac failure (grade III or IV of NYHA)
•Those at risk of arrhythmias
•Dehydration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified