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A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution

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ClinicalTrials.gov Identifier: NCT00389233
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
Norgine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Drug: Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate Drug: Macrogol3350 Na sulphate Na bicarbonate NaCl KCl Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : June 2002
Study Completion Date : December 2002

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
2L gut cleansing solution
 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.
Other Name: MOVIPREP®
Active Comparator: 2
4L preparation
 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.
Other Name: KLEAN-PREP®


Outcome Measures
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Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Degree of gut cleansing in each of the five colonic segments
  2. mean degree of gut cleansing
  3. global quality of gut cleansing
  4. overall ease to perform colonoscopy
  5. degree of patient satisfaction
  6. overall acceptability of the gut cleansing regimen
  7. global taste evaluation of the solution,problems drinking the entire volume of gut cleansing solution
  8. acceptability of the diet associated with the intake of the solution
  9. adverse events

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent prior to inclusion;
  • male or female in-patients, aged 18 to 85 years, with indication for complete colonoscopy;
  • willing and able to complete the entire procedure and to comply with study instructions;
  • females of childbearing potential employing an adequate method of contraception.

Exclusion Criteria:

  • ileus;
  • intestinal obstruction or perforation;
  • toxic megacolon;
  • congestive heart failure (NYHA class III and IV);
  • acute life-threatening cardiovascular disease;
  • untreated or uncontrolled arterial hypertension (SBP max>170mmHg, DBP min>100mmHg);
  • severe renal failure;
  • severe liver failure;
  • known glucose-6-phosphatase dehydrogenase deficiency;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389233


Locations
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Germany
Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien
Amberg, Germany, 92224
Chefarzt Innere Medizin, Klinikum Aschaffenburg
Aschaffenburg, Germany, 63739
Klinikum Dachau, Innere Medizin - Gastroenterologie
Dachau, Germany
Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk
Erfurt, Germany, 99097
Waldkrankenhaus St. Marien,
Erlangen, Germany, 91054
Zentrum für Innere Medizin,
Essen, Germany, 45239
Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie
Frankfurt/Main, Germany, 60318
Städtische Kliniken Frankfurt-Höchst
Frankfurt/Main, Germany, 65929
Klinikum Fürth, Med. Klinik II
Furth, Germany, 90766
Abteilung für Innere Medizin, Israelitisches Krankenhaus
Hamburg, Germany, 22297
Kreiskrankenhaus
Tirschenreuth, Germany, D-95643
Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Norgine
Investigators
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Principal Investigator: Christian Ell, Prof Dr med Dept. of Internal Medicine II, Dr.-Horst-Schmidt Hospital, Teaching Hospital of the University Mainz
More Information
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Publications of Results:
Ell C, Fischbach W, Bronisch JH, et al. Ergebnisse einer randomisierten, multizentrischen verblindeten Vergleichsstudie zur Wirksamkeit, Akzeptanz und Sicherheit einer neuen 2 Liter Darmvorbereitungslosung (Moviprep) im Vergleich zu einer etablierten 4 Liter Golytely Losung.[Results of a randomised, multi-centre, single-blinded trial to compare the efficacy, acceptability and safety of a new 2-litre gut cleansing solution versus a standard 4-litre PEG+E solution.] Z Gastroenterol 2004;42:P169
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Hans-Jürgen Gruss, Norgine
ClinicalTrials.gov Identifier: NCT00389233    
Other Study ID Numbers: NRL994-01/2001
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Ascorbic Acid
Polyethylene glycol 3350
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
 Vitamins
Micronutrients
Nutrients
Growth Substances
Laxatives
Gastrointestinal Agents