Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening
|ClinicalTrials.gov Identifier: NCT00427089|
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : April 16, 2008
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||September 2004|
|Study Completion Date :||May 2005|
2L gut cleansing solution
Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate
2L gut lavage solution
Other Name: MOVIPREP®
|Active Comparator: 2||
Drug: Sodium Phosphate solution (NaP)
45 ml solution; BID
- 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").
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427089
|Klinikum Aschaffenburg Am Hasenkopf 1|
|Aschaffenburg, Bayern, Germany, 63739|
|Augsburg, Bayern, Germany, 86150|
|Spardorfer Str. 39|
|Erlangen, Bayern, Germany, 91054|
|Hof, Bayern, Germany, 95028|
|Kirchheim, Bayern, Germany, 85551|
|Regensburg, Bayern, Germany, 93047|
|Dieburger Str. 29|
|Darmstadt, Hessen, Germany, 64287|
|Unter den Eichen 26|
|Oldenburg, Niedersachsen, Germany, 26122|
|Ludwigshafen, Rheinland-Pfalz, Germany, 67063|
|Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72|
|Erfurt, Thüringen, Germany, 99097|
|Minden, Westfalen-Lippe, Germany, 32423|
|Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14|
|Hamburg, Germany, 22297|
|Principal Investigator:||Christian Ell, Prof Dr med||Dr. Horst Schmidt Kliniken GmbH|