NCT01519609

Brief Summary

Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

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, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1.2 years

First QC Date

September 16, 2011

Last Update Submit

November 20, 2012

Conditions

Colorectal Cancer

Keywords

Bowel prepSafetyEfficacy

Outcome Measures

Primary Outcomes (1)

  • Degree of bowel cleansing

    Will be estimated by the patients and the colonoscopist

    1 Day of colonoscopy

Study Arms (2)

Moviprep

ACTIVE COMPARATOR

Moviprep bowel preb

Drug: bowel prep before endoscopy

Phosphoral

ACTIVE COMPARATOR

Bowel prep

Drug: bowel prep before endoscopy

Interventions

bowel prep before endoscopyDRUG

bowel prep before colonoscopy

MoviprepPhosphoral

Eligibility Criteria

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

You may qualify if:

  • Patients suspected of colorectal cancer scheduled for colonoscopy

You may not qualify if:

  • Patients with previous colorectal surgery
  • Colonis Stenosis
  • ASA \> 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Randers Regions Hospital

Randers, 8970, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • thorbjorn sommer, ph.D

    unaffilated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D Associate Professor

Study Record Dates

First Submitted

September 16, 2011

First Posted

January 27, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

DK(1)