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

Primary Purpose

Colonoscopy

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
Sodium Phosphate solution (NaP)
Sponsored by
Norgine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy focused on measuring Colon cleansing, Polyethylene Glycol, Sodium Phosphate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Klinikum Aschaffenburg Am Hasenkopf 1
  • Schiessgrabenstr. 34
  • Spardorfer Str. 39
  • Heiligengrabstr. 22
  • Rätestr. 20
  • Sternbergstr. 8
  • Dieburger Str. 29
  • Unter den Eichen 26
  • Erzbergstr. 113
  • Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
  • Uferstr. 3
  • Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

2L gut cleansing solution

Outcomes

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.

Full Information

First Posted
January 25, 2007
Last Updated
April 15, 2008
Sponsor
Norgine
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1. Study Identification

Unique Protocol Identification Number
NCT00427089
Brief Title
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Norgine

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy
Keywords
Colon cleansing, Polyethylene Glycol, Sodium Phosphate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
2L gut cleansing solution
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
Other Intervention Name(s)
MOVIPREP®
Intervention Description
2L gut lavage solution
Intervention Type
Drug
Intervention Name(s)
Sodium Phosphate solution (NaP)
Intervention Description
45 ml solution; BID
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
the "overall" judgment of the investigator for the colon preparation was documented.
Title
Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
Title
The taste of the solutions was assessed.
Title
Acceptability and tolerance for the subject was compared.
Title
All Adverse Events were recorded to evaluate the safety.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ell, Prof Dr med
Organizational Affiliation
Dr. Horst Schmidt Kliniken GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Aschaffenburg Am Hasenkopf 1
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Schiessgrabenstr. 34
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
Spardorfer Str. 39
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Heiligengrabstr. 22
City
Hof
State/Province
Bayern
ZIP/Postal Code
95028
Country
Germany
Facility Name
Rätestr. 20
City
Kirchheim
State/Province
Bayern
ZIP/Postal Code
85551
Country
Germany
Facility Name
Sternbergstr. 8
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93047
Country
Germany
Facility Name
Dieburger Str. 29
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64287
Country
Germany
Facility Name
Unter den Eichen 26
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26122
Country
Germany
Facility Name
Erzbergstr. 113
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
Facility Name
Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99097
Country
Germany
Facility Name
Uferstr. 3
City
Minden
State/Province
Westfalen-Lippe
ZIP/Postal Code
32423
Country
Germany
Facility Name
Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
City
Hamburg
ZIP/Postal Code
22297
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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; 38 (Suppl II): A18
Results Reference
result
PubMed Identifier
25180609
Citation
Ell C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23.
Results Reference
derived

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

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