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ColonoscopyPhase 3NCT00389233

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

A Phase 3 study testing Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate and Macrogol3350 Na sulphate Na bicarbonate NaCl KCl in people with Colonoscopy, run by Norgine at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colonoscopy
What is being tested?
Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate and Macrogol3350 Na sulphate Na bicarbonate NaCl KCl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
12 sitesGermany
Study dates
Jun 2002to Dec 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 9Show fewer
  • severe renal failure;
  • severe liver failure;
  • known glucose-6-phosphatase dehydrogenase deficiency;

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Chefarzt der Abt. Gastroenterologie, Klinikum St. Marien

    Amberg, 92224

  • Chefarzt Innere Medizin, Klinikum Aschaffenburg

    Aschaffenburg, 63739

  • Klinikum Dachau, Innere Medizin - Gastroenterologie

    Dachau

  • Chefarzt, Katholisches Krankenhaus St. Johann Nepomuk

    Erfurt, 99097

  • Waldkrankenhaus St. Marien,

    Erlangen, 91054

  • Zentrum für Innere Medizin,

    Essen, 45239

  • Bürgerhospital Frankfurt e.V., Abteilung für interventionelle Endoskopie

    Frankfurt am Main, 60318

  • Städtische Kliniken Frankfurt-Höchst

    Frankfurt am Main, 65929

  • Klinikum Fürth, Med. Klinik II

    Fürth, 90766

  • Abteilung für Innere Medizin, Israelitisches Krankenhaus

    Hamburg, 22297

  • Kreiskrankenhaus

    Tirschenreuth, D-95643

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

    Wiesbaden, 65199

Other trials in Germany

About this study

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.

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).

Read the 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
Being tested
Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate, Macrogol3350 Na sulphate Na bicarbonate NaCl KCl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbateDrug

    Also called MOVIPREP®

    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 KClDrug

    Also called KLEAN-PREP®

    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.

Study groups in NCT00389233
Study groupRoleWhat they receive
1Experimental2L gut cleansing solution
Receives: Drug: Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate
2Active comparator4L preparation
Receives: Drug: Macrogol3350 Na sulphate Na bicarbonate NaCl KCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2006 (estimated)
  2. Study startJun 2002
  3. Study completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389233
Sponsor's protocol ID
NRL994-01/2001
Status last verified
Apr 2008
First submitted
17 Oct 2006
Last updated
16 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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.

    PubMed 18190651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate and Macrogol3350 Na sulphate Na bicarbonate NaCl KCl in people with Colonoscopy, run by Norgine at 12 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00389233, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2008.

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