Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

April 15, 2008 updated by: Norgine

Parallel Group Comparison of the New 2 Liter Gut Cleansing Solution NRL 994 Versus Sodium Phosphate Preparation in Routine Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening.

To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies

Study Overview

Detailed Description

This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was 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

      • Hamburg, Germany, 22297
        • Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Klinikum Aschaffenburg Am Hasenkopf 1
      • Augsburg, Bayern, Germany, 86150
        • Schiessgrabenstr. 34
      • Erlangen, Bayern, Germany, 91054
        • Spardorfer Str. 39
      • Hof, Bayern, Germany, 95028
        • Heiligengrabstr. 22
      • Kirchheim, Bayern, Germany, 85551
        • Rätestr. 20
      • Regensburg, Bayern, Germany, 93047
        • Sternbergstr. 8
    • Hessen
      • Darmstadt, Hessen, Germany, 64287
        • Dieburger Str. 29
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26122
        • Unter den Eichen 26
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67063
        • Erzbergstr. 113
    • Thüringen
      • Erfurt, Thüringen, Germany, 99097
        • Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
    • Westfalen-Lippe
      • Minden, Westfalen-Lippe, Germany, 32423
        • Uferstr. 3

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject's written informed consent had to be obtained prior to inclusion.
  2. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
  3. Willing, able and competent to complete the entire procedure and to comply with study instructions
  4. Females of childbearing potential had to employ an adequate method of contraception

Exclusion Criteria:

  1. Ileus
  2. Intestinal obstruction or perforation
  3. Toxic megacolon
  4. History of colonic resection
  5. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
  6. Congestive heart failure (NYHA III + IV)
  7. Acute life threatening cardiovascular disease
  8. Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
  9. Known moderate to severe renal insufficiency
  10. Severe renal failure
  11. Severe liver failure
  12. Known glucose 6 phosphatase dehydrogenase deficiency
  13. Known phenylketonuria
  14. Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
  15. Concurrent participation in an investigational drug study or participation within 30 days of study entry
  16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
  17. Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.

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
Active Comparator: 2
45 ml solution; BID
Experimental: 1
2L gut cleansing solution
2L gut lavage solution
Other Names:
  • MOVIPREP®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").

Secondary Outcome Measures

Outcome Measure
the "overall" judgment of the investigator for the colon preparation was documented.
Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
The taste of the solutions was assessed.
Acceptability and tolerance for the subject was compared.
All Adverse Events were recorded to evaluate the safety.
Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Christian Ell, Prof Dr med, Dr. Horst Schmidt Kliniken GmbH

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

September 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

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

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.

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