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Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
This study has been completed.
Study NCT00427089   Information provided by Norgine
First Received: January 25, 2007   Last Updated: April 15, 2008   History of Changes

January 25, 2007
April 15, 2008
September 2004
 
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").
Same as current
Complete list of historical versions of study NCT00427089 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
 
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
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

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.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Colonoscopy
  • Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
  • Drug: Sodium Phosphate solution (NaP)
Experimental: 2L gut cleansing solution
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
360
May 2005
 

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00427089
Hans-Jürgen Gruss, Norgine
NRL 994-01/2004 (HSG)
Norgine
 
Principal Investigator: Christian Ell, Prof Dr med Dr. Horst Schmidt Kliniken GmbH
Norgine
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP