NCT02181920

Brief Summary

Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients with moderate to severe chronic cancer pain in comparison to administration of placebo or diclofenac.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4 pain

Status
terminated

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

March 1, 2000

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

July 2, 2014

Last Update Submit

July 17, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Change in morphine requirement

    Baseline, 9 days

Study Arms (4)

Metamizole - Diclofenac

EXPERIMENTAL

metamizole followed by diclofenac

Drug: MetamizoleDrug: DiclofenacDrug: Diclofenac placeboDrug: Metamizole placebo

Diclofenac - Metamizole

EXPERIMENTAL

diclofenac followed by metamizole

Drug: MetamizoleDrug: DiclofenacDrug: Diclofenac placeboDrug: Metamizole placebo

Metamizole - Placebo

EXPERIMENTAL

metamizole followed by placebo

Drug: MetamizoleDrug: Diclofenac placeboDrug: Metamizole placebo

Placebo - Metamizole

EXPERIMENTAL

placebo followed by metamizole

Drug: MetamizoleDrug: Diclofenac placeboDrug: Metamizole placebo

Interventions

MetamizoleDRUG
Diclofenac - MetamizoleMetamizole - DiclofenacMetamizole - PlaceboPlacebo - Metamizole
DiclofenacDRUG
Diclofenac - MetamizoleMetamizole - Diclofenac
Diclofenac placeboDRUG
Diclofenac - MetamizoleMetamizole - DiclofenacMetamizole - PlaceboPlacebo - Metamizole
Metamizole placeboDRUG
Diclofenac - MetamizoleMetamizole - DiclofenacMetamizole - PlaceboPlacebo - Metamizole

Eligibility Criteria

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

You may qualify if:

  • Hospitalized patients with neoplastic chronic pain requiring morphine treatment

You may not qualify if:

  • Karnofsky index less than 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

DipyroneDiclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 8, 2014

Study Start

March 1, 2000

Primary Completion

November 1, 2000

Last Updated

July 18, 2014

Record last verified: 2014-07