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

NCT ID: NCT00389233

Last Updated: 2008-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2002-12-31

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).

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

2L gut cleansing solution

Group Type: EXPERIMENTAL

Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate

Intervention Type: 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.

2

4L preparation

Group Type: ACTIVE_COMPARATOR

Macrogol3350 Na sulphate Na bicarbonate NaCl KCl

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MOVIPREP®; KLEAN-PREP®

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Norgine

Principal Investigators

Christian Ell, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien

Amberg, , Germany

Chefarzt Innere Medizin, Klinikum Aschaffenburg

Aschaffenburg, , Germany

Klinikum Dachau, Innere Medizin - Gastroenterologie

Dachau, , Germany

Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk

Erfurt, , Germany

Waldkrankenhaus St. Marien,

Erlangen, , Germany

Zentrum für Innere Medizin,

Essen, , Germany

Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie

Frankfurt am Main, , Germany

Städtische Kliniken Frankfurt-Höchst

Frankfurt am Main, , Germany

Klinikum Fürth, Med. Klinik II

Fürth, , Germany

Abteilung für Innere Medizin, Israelitisches Krankenhaus

Hamburg, , Germany

Kreiskrankenhaus

Tirschenreuth, , Germany

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

Wiesbaden, , Germany

Countries

Germany

References

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

Reference Type: 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

Reference Type: 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.

Reference Type: DERIVED

PMID: 18190651 (View on PubMed)

Other Identifiers

NRL994-01/2001

Identifier Type: -

Identifier Source: org_study_id