Clinical trial NCT00389233: A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: 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:
measure: Degree of gut cleansing in each of the five colonic segments
measure: mean degree of gut cleansing
measure: global quality of gut cleansing
measure: overall ease to perform colonoscopy
measure: degree of patient satisfaction
measure: overall acceptability of the gut cleansing regimen
measure: global taste evaluation of the solution,problems drinking the entire volume of gut cleansing solution
measure: acceptability of the diet associated with the intake of the solution
measure: adverse events
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien
city: Aschaffenburg
country: Germany
facility: Chefarzt Innere Medizin, Klinikum Aschaffenburg
city: Dachau
country: Germany
facility: Klinikum Dachau, Innere Medizin - Gastroenterologie
city: Erfurt
country: Germany
facility: Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk
city: Erlangen
country: Germany
facility: Waldkrankenhaus St. Marien,
city: Essen
country: Germany
facility: Zentrum für Innere Medizin,
city: Frankfurt/Main
country: Germany
facility: Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie
city: Frankfurt/Main
country: Germany
facility: Städtische Kliniken Frankfurt-Höchst
city: Furth
country: Germany
facility: Klinikum Fürth, Med. Klinik II
city: Hamburg
country: Germany
facility: Abteilung für Innere Medizin, Israelitisches Krankenhaus
city: Tirschenreuth
country: Germany
facility: Kreiskrankenhaus
city: Wiesbaden
country: Germany
facility: Dr.-Horst-Schmidt-Kliniken GmbH, Innere Medizin II
Study officials:
affiliation: Dept. of Internal Medicine II, Dr.-Horst-Schmidt Hospital, Teaching Hospital of the University Mainz
name: Christian Ell, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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
citation: 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.