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

Phase 3

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate; Drug: Sodium Phosphate solution (NaP)

• Registration Number: NCT00427089
• Lead Sponsor: Norgine

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-05
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-26
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate	2L gut cleansing solution
2	Sodium Phosphate solution (NaP)	-

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Sternbergstr. 8; 🇩🇪 Regensburg, Bayern, Germany

Spardorfer Str. 39; 🇩🇪 Erlangen, Bayern, Germany

Heiligengrabstr. 22; 🇩🇪 Hof, Bayern, Germany

Rätestr. 20; 🇩🇪 Kirchheim, Bayern, Germany

Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14; 🇩🇪 Hamburg, Germany

Dieburger Str. 29; 🇩🇪 Darmstadt, Hessen, Germany

Schiessgrabenstr. 34; 🇩🇪 Augsburg, Bayern, Germany

Klinikum Aschaffenburg Am Hasenkopf 1; 🇩🇪 Aschaffenburg, Bayern, Germany

Erzbergstr. 113; 🇩🇪 Ludwigshafen, Rheinland-Pfalz, Germany

Unter den Eichen 26; 🇩🇪 Oldenburg, Niedersachsen, Germany

Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72; 🇩🇪 Erfurt, Thüringen, Germany

Uferstr. 3; 🇩🇪 Minden, Westfalen-Lippe, Germany