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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00427089
• Date of registration: 25/01/2007
• Primary sponsor: Norgine
• Public title: Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
• Scientific title: 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.
• Date of first enrolment: September 2004
• Target sample size: 360
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00427089
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany

Contacts

• Name: Christian Ell, Prof Dr med
• Affiliation: Dr. Horst Schmidt Kliniken GmbH

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Colonoscopy

Intervention(s)

Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

Drug: Sodium Phosphate solution (NaP)

Primary Outcome(s)

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(s)

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.

Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.

the "overall" judgment of the investigator for the colon preparation was documented.

The taste of the solutions was assessed.

Secondary ID(s)

NRL 994-01/2004 (HSG)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors