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Sponsored by: |
Norgine |
Information provided by: | Norgine |
ClinicalTrials.gov Identifier: | NCT00389233 |
The study was carried out as a randomised, single-blind, active-controlled, multi-centric, phase III study with two parallel treatment groups. The primary efficacy criterion was the frequency of effective gut cleansing in each of the two treatment groups (grade A or B "overall quality of gut cleansing" as judged by a blinded expert panel on the basis of videotapes recorded during the endoscopic procedure).
Condition | Intervention | Phase |
Colonoscopy |
Drug: Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate Drug: Macrogol3350 Na sulphate Na bicarbonate NaCl KCl |
Phase III |
ChemIDplus related topics: | Ascorbic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Multi-Centre, Single-Blinded, Pivotal Phase III Trial to Assess the Efficacy, Acceptability and Safety of a New 2 Litre Gut Cleansing Solution NRL994 Versus a Standard Colon Preparation With 4L PEG+E. |
Enrollment: | 360 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | December 2002 |
Arms | Assigned Interventions |
1: Experimental
2L gut cleansing solution
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Drug: Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate
1 pack will consist of 2L NRL 994 - 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets for the 2L of 2 sachets (1 x "P" plus 1 x "C") will be dissolved in 1L of water. Each litre will be drunk within 1 hour followed by at least 500ml of any additional clear fluid.
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2: Active Comparator
4L preparation
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Drug: Macrogol3350 Na sulphate Na bicarbonate NaCl KCl
1 pack will consist of 4L PEG + E - contains 4 sachets for the 4L of PEG + E/"P/E". Each sachet will be dissolved in 1L of water. Each litre will be drunk within 1 hour.
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The study was designed as a randomised, active-controlled, single-blind, multi-centre, pivotal phase III trial with two parallel treatment groups. 15 German hospitals with specialised gastroenterology units were expected to participate in the investigation.
Up to 360 hospital in-patients routinely scheduled to undergo complete colonoscopy were to be enrolled one to two days prior to the endoscopic procedure, and to be randomly allocated to one of the two treatment arms in a ratio of 1:1. Bowel preparation was performed using equal split doses of either low-volume NRL994 (two doses of 1,000 mL each) or high-volume PEG+E (two doses of 2,000 mL each). The first dose was to be taken in the evening before the procedure, the second dose on the morning of the day of the colonoscopy. The patients allocated to NRL994 were asked to drink at least 1L of additional clear liquid in addition to the study drug. During colonoscopy the cleansing of each of the five pre-defined gut segments was to be assessed by the physician performing the examination, using a 5-level verbal rating scale. Videotapes were to be recorded of all procedures in order to allow central review by a blinded and independent expert panel whose ratings were the primary basis for the analysis of efficacy. The patients enrolled in the study were asked to fill in a questionnaire concerning the acceptability of the preparation. A patient's participation in the study was terminated upon completion of the intervention by performing a final examination and filling in the study termination page. No interim analysis was to be performed.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien | |||||
Amberg, Germany, 92224 | |||||
Abteilung für Innere Medizin, Israelitisches Krankenhaus | |||||
Hamburg, Germany, 22297 | |||||
Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II | |||||
Wiesbaden, Germany, 65199 | |||||
Chefarzt Innere Medizin, Klinikum Aschaffenburg | |||||
Aschaffenburg, Germany, 63739 | |||||
Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk | |||||
Erfurt, Germany, 99097 | |||||
Kreiskrankenhaus | |||||
Tirschenreuth, Germany, D-95643 | |||||
Städtische Kliniken Frankfurt-Höchst | |||||
Frankfurt/Main, Germany, 65929 | |||||
Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie | |||||
Frankfurt/Main, Germany, 60318 | |||||
Waldkrankenhaus St. Marien, | |||||
Erlangen, Germany, 91054 | |||||
Zentrum für Innere Medizin, | |||||
Essen, Germany, 45239 | |||||
Klinikum Fürth, Med. Klinik II | |||||
Furth, Germany, 90766 | |||||
Klinikum Dachau, Innere Medizin - Gastroenterologie | |||||
Dachau, Germany |
Norgine |
Principal Investigator: | Christian Ell, Prof Dr med | Dept. of Internal Medicine II, Dr.-Horst-Schmidt Hospital, Teaching Hospital of the University Mainz |
Ell C, Gruss HJ.Results of a Randomised, Multi-Centre, Single-Blind Trial to Compare the Efficacy, Acceptability and Safety of a New 2-Litre Gut Cleansing Solution Versus a Standard 4-Litre PEG+E Solution.Gastrointest Endosc 2004;59(5):AB125
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Responsible Party: | Norgine ( Dr Hans-Jürgen Gruss ) |
Study ID Numbers: | NRL994-01/2001 |
First Received: | October 17, 2006 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00389233 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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