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| Sponsored by: |
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 |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Ascorbic acid Sodium phosphate, dibasic |
| 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. |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Norgine |
| Principal Investigator: | Christian Ell, Prof Dr med | Dr. Horst Schmidt Kliniken GmbH |
More Information
|
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) |
| First Received: | January 25, 2007 |
| Last Updated: | April 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00427089 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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