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

NCT00389233 | Completed Phase 3

• 1 other identifier: NRL994-01/2001
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 12

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).

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (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 Outcomes (9)

• Degree of gut cleansing in each of the five colonic segments

• mean degree of gut cleansing

• global quality of gut cleansing

• overall ease to perform colonoscopy

• degree of patient satisfaction

Study Arms (2)

1

EXPERIMENTAL

2L gut cleansing solution

Drug: Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate

2

ACTIVE COMPARATOR

4L preparation

Drug: Macrogol3350 Na sulphate Na bicarbonate NaCl KCl

Interventions

Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate DRUG

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.

Also known as: MOVIPREP®

1

Macrogol3350 Na sulphate Na bicarbonate NaCl KCl DRUG

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.

Also known as: KLEAN-PREP®

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Norgine: lead

Study Sites (12)

Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien

Amberg, 92224, Germany

Location

Chefarzt Innere Medizin, Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

Location

Klinikum Dachau, Innere Medizin - Gastroenterologie

Dachau, Germany

Location

Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk

Erfurt, 99097, Germany

Location

Waldkrankenhaus St. Marien,

Erlangen, 91054, Germany

Location

Zentrum für Innere Medizin,

Essen, 45239, Germany

Location

Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie

Frankfurt am Main, 60318, Germany

Location

Städtische Kliniken Frankfurt-Höchst

Frankfurt am Main, 65929, Germany

Location

Klinikum Fürth, Med. Klinik II

Fürth, 90766, Germany

Location

Abteilung für Innere Medizin, Israelitisches Krankenhaus

Hamburg, 22297, Germany

Location

Kreiskrankenhaus

Tirschenreuth, D-95643, Germany

Location

Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II

Wiesbaden, 65199, Germany

Location

Related Publications (3)

• 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

  RESULT

• 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

  RESULT

• Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Runzi M, Schneider T, Kachel G, Gruger J, Kollinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol. 2008 Apr;103(4):883-93. doi: 10.1111/j.1572-0241.2007.01708.x. Epub 2008 Jan 11.

  PMID: 18190651 DERIVED

MeSH Terms

Interventions

MoviPrep; klean prep

Study Officials

• Christian Ell, Prof Dr med

  Dept. of Internal Medicine II, Dr.-Horst-Schmidt Hospital, Teaching Hospital of the University Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 18, 2006
• Study Start: June 1, 2002
• Study Completion: December 1, 2002
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

DE (12)