Bowel Preparation for Colonoscopy
Conditions
Interventions
Trade Name: Moviprep
Product Name: Moviprep
Pharmaceutical Form: Powder for oral solution
CAS Number: 0
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
Concentration type: equal
Co
Sponsors
Madaus GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gender: male/female Age: =18 years Scheduled for colonoscopy Subjects eligible for colorectal cancer screening Good state of health (no clinically significant deviations from normal clinical results and laboratory test findings) The subject must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects scheduled for emergency colonoscopy Subjects with unclear/undiagnosed abdominal pain and discomfort Laboratory values out of normal range unless the deviation from normal is judged as clinically not relevant by the investigator Existing severe cardiac, renal, metabolic or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, and bowel preparation procedure Existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, and bowel preparation procedure Subjects who had previous colonic resection surgery Known GI atresia or stenosis Suspicion of ileus, subileus Known coagulopathy Instable Diabetes mellitus Acute inflammatory bowel diseases (e.g. Crohn’s disease, ulcerative colitis, acute appendicitis) History of renal insufficiency Severe electrolyte disturbance, dehydration History of severe CNS and psychiatric disorders History of or current drug or alcohol abuse Use of drugs during the last week prior to the intended administration that can influence bowel transit times (e.g. laxatives, stool softeners, promotility agents, products to prevent diarrhoea, purgatives and enemas) Known intolerance and/or allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid, Plantago ovata seeds, Tinnevelly-senna pods, sucrose) Pregnancy Subjects suspected or known not to follow instructions Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or increased alcohol consumption or dependence Subject does not agree to abstain from alcohol for 24 hours prior to start of procedure Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study Participation in a clinical trial during the last month prior to the start of the study Vulnerable subjects The exclusion criteria are chosen to assure that subjects with specific risks for the procedure and administration of the investigated drug are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Test products compared with Reference product for bowel cleansing as rated by the Boston bowel preparation scale (BBPS);Secondary Objective: To assess subjective acceptance of taking the bowel preparation treatment for Test products in comparison with Reference product (VAS) To assess frequency of incomplete bowel preparation for Test products in comparison with Reference product To assess frequency of abdominal symptoms due to bowel preparation treatment for Test products in comparison with Reference product To assess frequency of incomplete colonoscopies with insufficient view due to low diagnostic quality at the first attempt for Test products in comparison with Reference product To assess characterisation of safety and tolerability of the investigational products considering Adverse Events, rate of nausea and emesis, blood electrolytes and vital signs in the study population for Test products in comparison with Reference product ;Primary end point(s): Mean of BBPS score | — |
Countries
Germany
Outcome results
None listed