NCT00427089

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

First QC Date

January 25, 2007

Last Update Submit

April 15, 2008

Conditions

Colonoscopy

Keywords

Colon cleansingPolyethylene GlycolSodium Phosphate

Outcome Measures

Primary Outcomes (1)

  • Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").

Secondary Outcomes (6)

  • the "overall" judgment of the investigator for the colon preparation was documented.

  • Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.

  • The taste of the solutions was assessed.

  • Acceptability and tolerance for the subject was compared.

  • All Adverse Events were recorded to evaluate the safety.

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

2L gut cleansing solution

Drug: Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na Ascorbate

2

ACTIVE COMPARATOR
Drug: Sodium Phosphate solution (NaP)

Interventions

Macrogol 3350 Na sulphate NaCl KCl Ascorbic Acid Na AscorbateDRUG

2L gut lavage solution

Also known as: MOVIPREP®
1
Sodium Phosphate solution (NaP)DRUG

45 ml solution; BID

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
  • Willing, able and competent to complete the entire procedure and to comply with study instructions
  • Females of childbearing potential had to employ an adequate method of contraception

You may not qualify if:

  • Ileus
  • Intestinal obstruction or perforation
  • Toxic megacolon
  • History of colonic resection
  • Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
  • Congestive heart failure (NYHA III + IV)
  • Acute life threatening cardiovascular disease
  • Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmHg)
  • Known moderate to severe renal insufficiency
  • Severe renal failure
  • Severe liver failure
  • Known glucose 6 phosphatase dehydrogenase deficiency
  • Known phenylketonuria
  • Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
  • Concurrent participation in an investigational drug study or participation within 30 days of study entry
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Klinikum Aschaffenburg Am Hasenkopf 1

Aschaffenburg, Bavaria, 63739, Germany

Location

Schiessgrabenstr. 34

Augsburg, Bavaria, 86150, Germany

Location

Spardorfer Str. 39

Erlangen, Bavaria, 91054, Germany

Location

Heiligengrabstr. 22

Hof, Bavaria, 95028, Germany

Location

Rätestr. 20

Kirchheim, Bavaria, 85551, Germany

Location

Sternbergstr. 8

Regensburg, Bavaria, 93047, Germany

Location

Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14

Hamburg, Hamburg, 22297, Germany

Location

Dieburger Str. 29

Darmstadt, Hesse, 64287, Germany

Location

Unter den Eichen 26

Oldenburg, Lower Saxony, 26122, Germany

Location

Erzbergstr. 113

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

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

Erfurt, Thuringia, 99097, Germany

Location

Uferstr. 3

Minden, Westfalen-Lippe, 32423, Germany

Location

Related Publications (2)

  • 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

    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.

    PMID: 25180609DERIVED

MeSH Terms

Interventions

MoviPrep

Study Officials

  • Christian Ell, Prof Dr med

    Dr. Horst Schmidt Kliniken GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 26, 2007

Study Start

September 1, 2004

Study Completion

May 1, 2005

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

DE(12)