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

Last updated: April 15, 2008
Sponsor: Norgine
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Treatment

N/A

Clinical Study ID

NCT00427089
NRL 994-01/2004 (HSG)
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 acomplete colonoscopy for colon cancer screening

  3. Willing, able and competent to complete the entire procedure and to comply with studyinstructions

  4. Females of childbearing potential had to employ an adequate method of contraception

Exclusion

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 30days of study entry

  16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearingpotential not using reliable methods of contraception

  17. Subject had a condition or was in a situation, which in the investigators opinionmight have put the subject at significant risk, might confound the study results, ormight interfere significantly.

Study Design

Total Participants: 360
Study Start date:
September 01, 2004
Estimated Completion Date:
May 31, 2005

Study 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.

Connect with a study center

  • Klinikum Aschaffenburg Am Hasenkopf 1

    Aschaffenburg, Bayern 63739
    Germany

    Site Not Available

  • Schiessgrabenstr. 34

    Augsburg, Bayern 86150
    Germany

    Site Not Available

  • Spardorfer Str. 39

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Heiligengrabstr. 22

    Hof, Bayern 95028
    Germany

    Site Not Available

  • Rätestr. 20

    Kirchheim, Bayern 85551
    Germany

    Site Not Available

  • Sternbergstr. 8

    Regensburg, Bayern 93047
    Germany

    Site Not Available

  • Dieburger Str. 29

    Darmstadt, Hessen 64287
    Germany

    Site Not Available

  • Unter den Eichen 26

    Oldenburg, Niedersachsen 26122
    Germany

    Site Not Available

  • Erzbergstr. 113

    Ludwigshafen, Rheinland-Pfalz 67063
    Germany

    Site Not Available

  • Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72

    Erfurt, Thüringen 99097
    Germany

    Site Not Available

  • Uferstr. 3

    Minden, Westfalen-Lippe 32423
    Germany

    Site Not Available

  • Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14

    Hamburg, 22297
    Germany

    Site Not Available

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