Metamizol for the Treatment of Neoplastic Chronic Pain

July 17, 2014 updated by: Boehringer Ingelheim

Analgesic Effect of a New Metamizol Oral Pharmaceutical Form for the Treatment of the Neoplastic Chronic Pain: Randomized, Double-blind Crossover Clinical Trial Between Metamizol, Diclofenac and Placebo

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patients with neoplastic chronic pain requiring morphine treatment

Exclusion Criteria:

  • Karnofsky index less than 30%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metamizole - Diclofenac
metamizole followed by diclofenac
Drug: Diclofenac
Drug: Metamizole
Drug: Diclofenac placebo
Drug: Metamizole placebo
Experimental: Diclofenac - Metamizole
diclofenac followed by metamizole
Drug: Diclofenac
Drug: Metamizole
Drug: Diclofenac placebo
Drug: Metamizole placebo
Experimental: Metamizole - Placebo
metamizole followed by placebo
Drug: Metamizole
Drug: Diclofenac placebo
Drug: Metamizole placebo
Experimental: Placebo - Metamizole
placebo followed by metamizole
Drug: Metamizole
Drug: Diclofenac placebo
Drug: Metamizole placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in morphine requirement
Time Frame: Baseline, 9 days
Baseline, 9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1093.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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