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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.


Phase 3
18 Years
85 Years
Not Enrolling
Both
Colonoscopy

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

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").

Principal Investigator

Christian Ell, Prof Dr med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr. Horst Schmidt Kliniken GmbH

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NRL 994-01/2004 (HSG)

NCT ID:

NCT00427089

Start Date:

September 2004

Completion Date:

May 2005

Related Keywords:

  • Colonoscopy
  • Colon cleansing
  • Polyethylene Glycol
  • Sodium Phosphate
  • Colonic Neoplasms

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