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

Sponsor:	Norgine
Information provided by:	Norgine
ClinicalTrials.gov Identifier:	NCT00427089

Purpose

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	Intervention	Phase
Colonoscopy	Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate Drug: Sodium Phosphate solution (NaP)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy

Drug Information available for: Ascorbic acid Sodium phosphate, dibasic

U.S. FDA Resources

Further study details as provided by Norgine:

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.

Enrollment:	360
Study Start Date:	September 2004
Estimated Study Completion Date:	May 2005

Arms	Assigned Interventions
1: Experimental 2L gut cleansing solution	Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate 2L gut lavage solution
2: Active Comparator	Drug: Sodium Phosphate solution (NaP) 45 ml solution; BID

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427089

Locations

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

Sponsors and Collaborators

Norgine

Investigators

Principal Investigator:

Christian Ell, Prof Dr med

Dr. Horst Schmidt Kliniken GmbH

More Information

Publications:

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

Responsible Party:	Norgine ( Hans-Jürgen Gruss )
Study ID Numbers:	NRL 994-01/2004 (HSG)
Study First Received:	January 25, 2007
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00427089 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Norgine:

Colon cleansing
Polyethylene Glycol
Sodium Phosphate

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Gastrointestinal Agents
Cathartics
Protective Agents

Pharmacologic Actions
Sodium phosphate
Vitamins
Therapeutic Uses
Micronutrients
Ascorbic Acid

ClinicalTrials.gov processed this record on November 27, 2009