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

Colonoscopy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427089
• Other study ID #: NRL 994-01/2004 (HSG)
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2007
• Last updated: April 15, 2008
• Start date: September 2004
• Est. completion date: May 2005

Study information

• Verified date: April 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
2L gut lavage solution
• Sodium Phosphate solution (NaP)
45 ml solution; BID

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg Am Hasenkopf 1	Aschaffenburg	Bayern
Germany	Schiessgrabenstr. 34	Augsburg	Bayern
Germany	Dieburger Str. 29	Darmstadt	Hessen
Germany	Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72	Erfurt	Thüringen
Germany	Spardorfer Str. 39	Erlangen	Bayern
Germany	Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14	Hamburg
Germany	Heiligengrabstr. 22	Hof	Bayern
Germany	Rätestr. 20	Kirchheim	Bayern
Germany	Erzbergstr. 113	Ludwigshafen	Rheinland-Pfalz
Germany	Uferstr. 3	Minden	Westfalen-Lippe
Germany	Unter den Eichen 26	Oldenburg	Niedersachsen
Germany	Sternbergstr. 8	Regensburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ell C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the "overall" judgment of the investigator for the colon preparation was documented.
Secondary	Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
Secondary	The taste of the solutions was assessed.
Secondary	Acceptability and tolerance for the subject was compared.
Secondary	All Adverse Events were recorded to evaluate the safety.
Secondary	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.