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A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution

NCT00389233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2008-04-16

No results posted yet for this study

Summary

The study was carried out as a randomised, single-blind, active-controlled, multi-centric, phase III study with two parallel treatment groups. The primary efficacy criterion was the frequency of effective gut cleansing in each of the two treatment groups (grade A or B "overall quality of gut cleansing" as judged by a blinded expert panel on the basis of videotapes recorded during the endoscopic procedure).

Conditions

  • Colonoscopy

Interventions

DRUG

Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate

1 pack will consist of 2L NRL 994 - 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets for the 2L of 2 sachets (1 x "P" plus 1 x "C") will be dissolved in 1L of water. Each litre will be drunk within 1 hour followed by at least 500ml of any additional clear fluid.

DRUG

Macrogol3350 Na sulphate Na bicarbonate NaCl KCl

1 pack will consist of 4L PEG + E - contains 4 sachets for the 4L of PEG + E/"P/E". Each sachet will be dissolved in 1L of water. Each litre will be drunk within 1 hour.

Sponsors & Collaborators

Principal Investigators

  • Christian Ell, Prof Dr med · Dept. of Internal Medicine II, Dr.-Horst-Schmidt Hospital, Teaching Hospital of the University Mainz

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
2002-06-30
Completion
2002-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00389233 on ClinicalTrials.gov