A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
PAREXEL International Early Product Development Unit
Berlin, Germany
Parexel International GmbH
Berlin, Germany
Stool weight output
Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours
Time frame: 36 hours post-dose
Cleansing success rate
The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
Time frame: 36 hours post-dose
Tolerability of medication (vomiting rate)
The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B
Time frame: 36 hours post-dose
EQ 5D patient questionnaire outcome (Part A only)
Patients to use the EQ 5D patient questionnaire to assess their study medication for part A
Time frame: 36 hours post-dose
Cleansing scores for each colon segment
The segmental cleansing scores for each of the five colon segments
Time frame: 36 hours post-dose
Time and volume of IMP to reach a clear effluent
The time and volume taken for the IMP to reach a clear effluent
Time frame: 36 hours post-dose
Ascorbate concentration
Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)
Time frame: 36 hours post-dose
Electrolytes concentration
Concentration of electrolytes in blood, urine and faeces
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Time frame: 36 hours post-dose
PEG3350 concentration
Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities
Time frame: 36 hours post-dose