Aims:
Quality of inspection during colonoscopy is strictly related to the level of cleansing.
High-volume solutions are highly effective and safe, but high volume affects tolerability
and compliance. Aim of this study was to compare a new low volume PEG with citrate
and simethicone solution (PMF 104, Clensia®) with a low volume PEG with ascorbic acid
solution (PEG-ASC; Moviprep®).
Methods:
This is a multicenter, randomized, observer-blind, parallel-group, phase-3 clinical
trial. Patients were randomized between PMF 104 and PEG-ASC. In both groups, patients
were instructed to take a full dose regimen the evening before if colonoscopy was
scheduled before 11 – 12 am, or to take a split regimen if colonoscopy was scheduled
after 11 – 12 am. Primary end-point was an equivalence between PMF104 and PEG-ASC
in the rate of adequate level of cleansing (Ottawa scale ≤6), with safety, mucosal
visibility, tolerability, acceptance and compliance being also assessed.
Results:
Of the 403 enrolled patients 367 patients (Mean age (SD): 55.6 (14.4) years; male:
166 (45.2%)) were included in the per protocol (PP) analysis: 184 being randomized
in the PMF 104 group and the remaining 183 in the PEG-ASC. Overall, rate of successful
bowel cleansing was 78.3% in PMF104 and 74.3% in PEG-ASC (p = 0.37). Successful bowel
cleansing was higher with split dose regimen (86.2% for PMF 104 and 78.7% for PEG-ASC)
as compared with full dose regimen (75% for PMF104 and 72.5% for PEG-ASC). Both the
preparations were equally safe (9.2% of patients in the PMF104 and 9.3% of patients
in the PEG-ASC groups experienced mild adverse events) and acceptable (patients reported
no or mild distress during the intake in 81.4% in the PMF104 and 80.8% in the PEG-ASC,
p = 0.74).
Conclusions:
The new low volume product Clensia® is equivalent to the reference low volume PEG-ASC
in terms of bowel cleansing, safety and acceptance.
