Back to resultsMetamizol for the Treatment of Neoplastic Chronic Pain
Primary Purpose
Pain
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metamizole
Diclofenac
Diclofenac placebo
Metamizole placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients with neoplastic chronic pain requiring morphine treatment
Exclusion Criteria:
- Karnofsky index less than 30%
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Metamizole - Diclofenac
Diclofenac - Metamizole
Metamizole - Placebo
Placebo - Metamizole
Arm Description
metamizole followed by diclofenac
diclofenac followed by metamizole
metamizole followed by placebo
placebo followed by metamizole
Outcomes
Primary Outcome Measures
Change in morphine requirement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02181920
Brief Title
Metamizol for the Treatment of Neoplastic Chronic Pain
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
March 2000 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metamizole - Diclofenac
Arm Type
Experimental
Arm Description
metamizole followed by diclofenac
Arm Title
Diclofenac - Metamizole
Arm Type
Experimental
Arm Description
diclofenac followed by metamizole
Arm Title
Metamizole - Placebo
Arm Type
Experimental
Arm Description
metamizole followed by placebo
Arm Title
Placebo - Metamizole
Arm Type
Experimental
Arm Description
placebo followed by metamizole
Intervention Type
Drug
Intervention Name(s)
Metamizole
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Type
Drug
Intervention Name(s)
Diclofenac placebo
Intervention Type
Drug
Intervention Name(s)
Metamizole placebo
Primary Outcome Measure Information:
Title
Change in morphine requirement
Time Frame
Baseline, 9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients with neoplastic chronic pain requiring morphine treatment
Exclusion Criteria:
Karnofsky index less than 30%
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Metamizol for the Treatment of Neoplastic Chronic Pain
We'll reach out to this number within 24 hrs