A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

Summary

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.

Timeline

Start

2014-11

Primary completion

2015-06

Completion

2015-06

Outcome

Met primary endpoint

paper Results Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95 % confidence intervals [CI]: -4.99, -2.97; P < 0.0001) in the intent-to-treat analysis set. PMID 28393103 ↗

registry PICOPREP Day-before Dosing Schedule vs PICOPREP Tailored Dosing Schedule; p <0.0001; Adjusted estimated mean difference -3.93 (95% CI -4.99 to -2.87); ANCOVA; note: p-value corresponds to a two-sided test of superiority. NCT02239692 ↗

registry PICOPREP Day-before Dosing Schedule vs PICOPREP Tailored Dosing Schedule; p <0.0001; Adjusted estimated mean difference -4.38 (95% CI -5.34 to -3.41); ANCOVA; note: p-value corresponds to a two-sided test of superiority. NCT02239692 ↗

Publications

• Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PICOPREP	Small molecule	—	Oral

Indications

No indication recorded.