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

Sponsor

Norgine (Industry)

Overall Status

Completed

CT.gov ID

NCT00427089

Collaborator

(none)

360

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate Drug: Sodium Phosphate solution (NaP)	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Sep 1, 2004

Study Completion Date :

May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 2L gut cleansing solution	Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate 2L gut lavage solution Other Names: MOVIPREP®
Active Comparator: 2	Drug: Sodium Phosphate solution (NaP) 45 ml solution; BID

Arm

Intervention/Treatment

Experimental: 1

2L gut cleansing solution

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

2L gut lavage solution

Other Names:

MOVIPREP®

Active Comparator: 2

Drug: Sodium Phosphate solution (NaP)

45 ml solution; BID

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The subject's written informed consent had to be obtained prior to inclusion.
Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
Willing, able and competent to complete the entire procedure and to comply with study instructions
Females of childbearing potential had to employ an adequate method of contraception

Exclusion Criteria:

Ileus
Intestinal obstruction or perforation
Toxic megacolon
History of colonic resection
Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
Congestive heart failure (NYHA III + IV)
Acute life threatening cardiovascular disease
Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
Known moderate to severe renal insufficiency
Severe renal failure
Severe liver failure
Known glucose 6 phosphatase dehydrogenase deficiency
Known phenylketonuria
Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
Concurrent participation in an investigational drug study or participation within 30 days of study entry
Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Aschaffenburg Am Hasenkopf 1	Aschaffenburg	Bayern	Germany	63739
2	Schiessgrabenstr. 34	Augsburg	Bayern	Germany	86150
3	Spardorfer Str. 39	Erlangen	Bayern	Germany	91054
4	Heiligengrabstr. 22	Hof	Bayern	Germany	95028
5	Rätestr. 20	Kirchheim	Bayern	Germany	85551
6	Sternbergstr. 8	Regensburg	Bayern	Germany	93047
7	Dieburger Str. 29	Darmstadt	Hessen	Germany	64287
8	Unter den Eichen 26	Oldenburg	Niedersachsen	Germany	26122
9	Erzbergstr. 113	Ludwigshafen	Rheinland-Pfalz	Germany	67063
10	Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72	Erfurt	Thüringen	Germany	99097
11	Uferstr. 3	Minden	Westfalen-Lippe	Germany	32423
12	Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14	Hamburg		Germany	22297