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drugset / Trial / NCT03106922

A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children

NCT03106922 ↗

Phase 3 Unknown 430 enrolled Alfasigma S.p.A.
RandomizedParallel-groupSingle-blindTreatment

Summary

A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

Timeline

Start
2016-04
Primary completion
2020-07
Completion
2020-07

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG 4000 Unknown 52.5 g Oral
Subject Potassium Chloride Small molecule 0.37 g Oral
Subject Potassium Chloride Small molecule 0.7425 g Oral
Subject anhydrous citric acid Unknown 0.813 g Oral
Subject anhydrous sodium sulphate Unknown 3.75 g Oral
Subject anhydrous sodium sulphate Unknown 5.685 g Oral
Subject polyethylene glycol Other / unclassified 59 g Oral
Subject simeticone Unknown 0.08 g Oral
Subject sodium bicarbonate Diagnostic / imaging agent 1.685 g Oral
Subject sodium chloride Unknown 0.73 g Oral
Subject sodium chloride Unknown 1.465 g Oral
Subject sodium citrate Unknown 1.863 g Oral

Indications

No indication recorded.