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

Colonoscopy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389233
• Other study ID #: NRL994-01/2001
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2006
• Last updated: April 15, 2008
• Start date: June 2002
• Est. completion date: December 2002

Study information

• Verified date: April 2008
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	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/Main
Germany	Städtische Kliniken Frankfurt-Höchst	Frankfurt/Main
Germany	Klinikum Fürth, Med. Klinik II	Furth
Germany	Abteilung für Innere Medizin, Israelitisches Krankenhaus	Hamburg
Germany	Kreiskrankenhaus	Tirschenreuth
Germany	Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 Li

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of gut cleansing in each of the five colonic segments
Secondary	mean degree of gut cleansing
Secondary	global quality of gut cleansing
Secondary	overall ease to perform colonoscopy
Secondary	degree of patient satisfaction
Secondary	overall acceptability of the gut cleansing regimen
Secondary	global taste evaluation of the solution,problems drinking the entire volume of gut cleansing solution
Secondary	acceptability of the diet associated with the intake of the solution
Secondary	adverse events