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

April 15, 2008 updated by: Norgine

A Randomised, Multi-Centre, Single-Blinded, Pivotal Phase III Trial to Assess the Efficacy, Acceptability and Safety of a New 2 Litre Gut Cleansing Solution NRL994 Versus a Standard Colon Preparation With 4L PEG+E.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a randomised, active-controlled, single-blind, multi-centre, pivotal phase III trial with two parallel treatment groups. 15 German hospitals with specialised gastroenterology units were expected to participate in the investigation.

Up to 360 hospital in-patients routinely scheduled to undergo complete colonoscopy were to be enrolled one to two days prior to the endoscopic procedure, and to be randomly allocated to one of the two treatment arms in a ratio of 1:1. Bowel preparation was performed using equal split doses of either low-volume NRL994 (two doses of 1,000 mL each) or high-volume PEG+E (two doses of 2,000 mL each). The first dose was to be taken in the evening before the procedure, the second dose on the morning of the day of the colonoscopy. The patients allocated to NRL994 were asked to drink at least 1L of additional clear liquid in addition to the study drug. During colonoscopy the cleansing of each of the five pre-defined gut segments was to be assessed by the physician performing the examination, using a 5-level verbal rating scale. Videotapes were to be recorded of all procedures in order to allow central review by a blinded and independent expert panel whose ratings were the primary basis for the analysis of efficacy. The patients enrolled in the study were asked to fill in a questionnaire concerning the acceptability of the preparation. A patient's participation in the study was terminated upon completion of the intervention by performing a final examination and filling in the study termination page. No interim analysis was to be performed.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany, 92224
        • Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien
      • Aschaffenburg, Germany, 63739
        • Chefarzt Innere Medizin, Klinikum Aschaffenburg
      • Dachau, Germany
        • Klinikum Dachau, Innere Medizin - Gastroenterologie
      • Erfurt, Germany, 99097
        • Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk
      • Erlangen, Germany, 91054
        • Waldkrankenhaus St. Marien,
      • Essen, Germany, 45239
        • Zentrum für Innere Medizin,
      • Frankfurt/Main, Germany, 60318
        • Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie
      • Frankfurt/Main, Germany, 65929
        • Stadtische Kliniken Frankfurt-Hochst
      • Furth, Germany, 90766
        • Klinikum Fürth, Med. Klinik II
      • Hamburg, Germany, 22297
        • Abteilung für Innere Medizin, Israelitisches Krankenhaus
      • Tirschenreuth, Germany, D-95643
        • Kreiskrankenhaus
      • Wiesbaden, Germany, 65199
        • Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent prior to inclusion;
  • male or female in-patients, aged 18 to 85 years, with indication for complete colonoscopy;
  • willing and able to complete the entire procedure and to comply with study instructions;
  • females of childbearing potential employing an adequate method of contraception.

Exclusion Criteria:

  • ileus;
  • intestinal obstruction or perforation;
  • toxic megacolon;
  • congestive heart failure (NYHA class III and IV);
  • acute life-threatening cardiovascular disease;
  • untreated or uncontrolled arterial hypertension (SBP max>170mmHg, DBP min>100mmHg);
  • severe renal failure;
  • severe liver failure;
  • known glucose-6-phosphatase dehydrogenase deficiency;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
2L gut cleansing solution
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.
Other Names:
  • MOVIPREP®
Active Comparator: 2
4L preparation
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.
Other Names:
  • KLEAN-PREP®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).

Secondary Outcome Measures

Outcome Measure
adverse events
Degree of gut cleansing in each of the five colonic segments
mean degree of gut cleansing
global quality of gut cleansing
overall ease to perform colonoscopy
degree of patient satisfaction
overall acceptability of the gut cleansing regimen
global taste evaluation of the solution,problems drinking the entire volume of gut cleansing solution
acceptability of the diet associated with the intake of the solution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norgine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 18, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRL994-01/2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe