NCT01541111

Brief Summary

This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3.2 years

First QC Date

February 17, 2012

Last Update Submit

July 27, 2015

Conditions

Cancer-related Problem/Condition

Keywords

Cancer painMagnesiun

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    12 wk

Secondary Outcomes (1)

  • Morphine dose

    12 wk

Study Arms (1)

Magnesiun, pain relief, sugar pills

OTHER

Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h

Drug: Magnesiun

Interventions

MagnesiunDRUG

75mg pills; each 12h; 12wk

Also known as: NMDA receptor antagonist
Magnesiun, pain relief, sugar pills

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • After approval by the Ethics Committee and signed informed consent,
  • patients, \> 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied

You may not qualify if:

  • Were excluded from the study patients with hypersensitivity to drugs and pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04023062, Brazil

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

GluN2C-2D antagonist UBP145

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rioko K Sakata, MD, PhD

    Universidade Federal de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 29, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

BR(1)