This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
204
Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Ed Herriot Hopital (there may be other sites in this country)
Lyon, France
Gastroenterologie am Bayerischen Platz (there may be other sites in this country)
Berlin, Germany
Medisch Centrum Alkmaar (there may be other sites in this country)
Alkmaar, Netherlands
Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Time frame: Day 1 (day of colonoscopy)
Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
Time frame: Day 1 (day of colonoscopy)
Ascending Colon Cleansing Responder Status (ITT)
Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.
Time frame: Day 1 (day of colonoscopy)
Frequency and Intensity of Adverse Events
Time frame: From baseline (screening) up to day 10 after colonoscopy
Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).
Time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.
Time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)