- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00427089
Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
April 15, 2008 updated by: Norgine
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.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 22297
- Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
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Bayern
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Aschaffenburg, Bayern, Germany, 63739
- Klinikum Aschaffenburg Am Hasenkopf 1
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Augsburg, Bayern, Germany, 86150
- Schiessgrabenstr. 34
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Erlangen, Bayern, Germany, 91054
- Spardorfer Str. 39
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Hof, Bayern, Germany, 95028
- Heiligengrabstr. 22
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Kirchheim, Bayern, Germany, 85551
- Rätestr. 20
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Regensburg, Bayern, Germany, 93047
- Sternbergstr. 8
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Hessen
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Darmstadt, Hessen, Germany, 64287
- Dieburger Str. 29
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Niedersachsen
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Oldenburg, Niedersachsen, Germany, 26122
- Unter den Eichen 26
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Rheinland-Pfalz
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Ludwigshafen, Rheinland-Pfalz, Germany, 67063
- Erzbergstr. 113
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Thüringen
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Erfurt, Thüringen, Germany, 99097
- Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72
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Westfalen-Lippe
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Minden, Westfalen-Lippe, Germany, 32423
- Uferstr. 3
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
45 ml solution; BID
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Experimental: 1
2L gut cleansing solution
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2L gut lavage solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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").
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Secondary Outcome Measures
Outcome Measure |
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the "overall" judgment of the investigator for the colon preparation was documented.
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Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
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The taste of the solutions was assessed.
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Acceptability and tolerance for the subject was compared.
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All Adverse Events were recorded to evaluate the safety.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Ell, Prof Dr med, Dr. Horst Schmidt Kliniken GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
January 25, 2007
First Submitted That Met QC Criteria
January 25, 2007
First Posted (Estimate)
January 26, 2007
Study Record Updates
Last Update Posted (Estimate)
April 16, 2008
Last Update Submitted That Met QC Criteria
April 15, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Laxatives
- Ascorbic Acid
- Polyethylene glycol 3350
Other Study ID Numbers
- NRL 994-01/2004 (HSG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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