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Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

NCT01509131 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2012-01-12

No results posted yet for this study

Summary

It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.

Conditions

  • Colonoscopy

Interventions

DRUG

2L PEG-CS plus bisacodyl

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

DRUG

2L PEG-ASC

Patients will asked to take PEG-ASC according to labeling instructions

Sponsors & Collaborators

  • Promefarm S.r.l.

    lead INDUSTRY

Principal Investigators

  • Alessandro Repici, MD · IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy

  • Renzo Cestari, Prof. MD · Spedali Civili di Brescia, Brescia - Italy

  • Cesare Hassan, MD · Nuovo Regina Margherita, Roma - Italy

  • Angelo Andriulli, MD · IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy

  • Vito Annese, MD · Ospedale Careggi, Firenze - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509131 on ClinicalTrials.gov