NCT00427492

Brief Summary

Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

January 26, 2007

Last Update Submit

February 10, 2009

Conditions

Colonic Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to defecation after colonic resection

    2-8 days

Study Arms (2)

Magnesia

ACTIVE COMPARATOR

Medical laxative

Drug: MagnesiaDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MagnesiaDRUG

Tablet magnesia 500mg. 2 tablet 2 times a day for a week

Magnesia
PlaceboDRUG
MagnesiaPlacebo

Eligibility Criteria

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

You may qualify if:

  • Patients with planned elective colonic resection

You may not qualify if:

  • Previous extended abdominal surgery
  • Pregnancy
  • Opioid or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University hospital Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Jens Andersen, MD

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 29, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

DK(1)