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Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies

NCT01251237 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-12-01

No results posted yet for this study

Summary

It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.

Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.

Conditions

Interventions

DRUG

NRL0706

Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.

Sponsors & Collaborators

Principal Investigators

  • Wolfgang Fischbach, Prof Dr med · Klinikum Aschaffenburg-Alzenau

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Germany

Study Locations

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Diseases
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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 NCT01251237 on ClinicalTrials.gov