MedDataX Logo

Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

NCT ID: NCT00427089

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colon cleansing Polyethylene Glycol Sodium Phosphate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

2L gut cleansing solution

Group Type EXPERIMENTAL

Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

Intervention Type DRUG

2L gut lavage solution

2

Group Type ACTIVE_COMPARATOR

Sodium Phosphate solution (NaP)

Intervention Type DRUG

45 ml solution; BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

2L gut lavage solution

Intervention Type DRUG

Sodium Phosphate solution (NaP)

45 ml solution; BID

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MOVIPREP®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The subject's written informed consent had to be obtained prior to inclusion.
2. Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
3. Willing, able and competent to complete the entire procedure and to comply with study instructions
4. Females of childbearing potential had to employ an adequate method of contraception

Exclusion Criteria

1. Ileus
2. Intestinal obstruction or perforation
3. Toxic megacolon
4. History of colonic resection
5. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
6. Congestive heart failure (NYHA III + IV)
7. Acute life threatening cardiovascular disease
8. Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmHg)
9. Known moderate to severe renal insufficiency
10. Severe renal failure
11. Severe liver failure
12. Known glucose 6 phosphatase dehydrogenase deficiency
13. Known phenylketonuria
14. Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
15. Concurrent participation in an investigational drug study or participation within 30 days of study entry
16. Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
17. Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norgine

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Norgine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Ell, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Dr. Horst Schmidt Kliniken GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Klinikum Aschaffenburg Am Hasenkopf 1

Aschaffenburg, Bavaria, Germany

Site Status

Schiessgrabenstr. 34

Augsburg, Bavaria, Germany

Site Status

Spardorfer Str. 39

Erlangen, Bavaria, Germany

Site Status

Heiligengrabstr. 22

Hof, Bavaria, Germany

Site Status

Rätestr. 20

Kirchheim, Bavaria, Germany

Site Status

Sternbergstr. 8

Regensburg, Bavaria, Germany

Site Status

Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14

Hamburg, City state of Hamburg, Germany

Site Status

Dieburger Str. 29

Darmstadt, Hesse, Germany

Site Status

Unter den Eichen 26

Oldenburg, Lower Saxony, Germany

Site Status

Erzbergstr. 113

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

Kath. Krankenhaus St. Johann Nepomuk Abt. für Endoskopie Haarbergstr. 72

Erfurt, Thuringia, Germany

Site Status

Uferstr. 3

Minden, Westfalen-Lippe, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Ell C, Fischbach W, Layer P, Boehm G, Bokemeyer B, Frick B, et al. Polyethylene Glycol with electrolytes and ascorbic acid versus sodium phosphate for bowel cleansing before coloscopy for cancer screening: a randomised, controlled trial. Endoscopy 2006; 38 (Suppl II): A18

Reference Type RESULT

Ell C, Fischbach W, Layer P, Halphen M. Randomized, controlled trial of 2 L polyethylene glycol plus ascorbate components versus sodium phosphate for bowel cleansing prior to colonoscopy for cancer screening. Curr Med Res Opin. 2014 Dec;30(12):2493-503. doi: 10.1185/03007995.2014.960513. Epub 2014 Sep 23.

Reference Type DERIVED
PMID: 25180609 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NRL 994-01/2004 (HSG)

Identifier Type: -

Identifier Source: org_study_id