PainPhase 4NCT02181920
Metamizol for the Treatment of Neoplastic Chronic Pain
A Phase 4 study testing Metamizole and Diclofenac in people with Pain, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Metamizole and Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Nov 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with neoplastic chronic pain requiring morphine treatment
Who cannot join
- Karnofsky index less than 30%
About this study
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 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.
- Conditions
- Pain
- Being tested
- Metamizole, Diclofenac, Diclofenac placebo, Metamizole placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizoleDrug
DiclofenacDrug
Diclofenac placeboDrug
Metamizole placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Metamizole - Diclofenac | Experimental | metamizole followed by diclofenac Receives: Drug: Metamizole; Drug: Diclofenac; Drug: Diclofenac placebo; Drug: Metamizole placebo |
| Diclofenac - Metamizole | Experimental | diclofenac followed by metamizole Receives: Drug: Metamizole; Drug: Diclofenac; Drug: Diclofenac placebo; Drug: Metamizole placebo |
| Metamizole - Placebo | Experimental | metamizole followed by placebo Receives: Drug: Metamizole; Drug: Diclofenac placebo; Drug: Metamizole placebo |
| Placebo - Metamizole | Experimental | placebo followed by metamizole Receives: Drug: Metamizole; Drug: Diclofenac placebo; Drug: Metamizole placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in morphine requirement
Measured: Baseline, 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMar 2000
- Primary completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181920
- Sponsor's protocol ID
- 1093.14
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02181920
- Acronym / sponsor ID
- 1093.14
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Nov 2000 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metamizole - Diclofenac | Experimental | Drug: Metamizole, Drug: Diclofenac, Drug: Diclofenac placebo, Drug: Metamizole placebometamizole followed by diclofenac |
| Diclofenac - Metamizole | Experimental | Drug: Metamizole, Drug: Diclofenac, Drug: Diclofenac placebo, Drug: Metamizole placebodiclofenac followed by metamizole |
| Metamizole - Placebo | Experimental | Drug: Metamizole, Drug: Diclofenac placebo, Drug: Metamizole placebometamizole followed by placebo |
| Placebo - Metamizole | Experimental | Drug: Metamizole, Drug: Diclofenac placebo, Drug: Metamizole placeboplacebo followed by metamizole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with neoplastic chronic pain requiring morphine treatment
Key exclusion criteria (1 listed)
- Karnofsky index less than 30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metamizole | Drug | Diclofenac - Metamizole, Metamizole - Diclofenac, Metamizole - Placebo, Placebo - Metamizole |
| Diclofenac | Drug | Diclofenac - Metamizole, Metamizole - Diclofenac |
| Diclofenac placebo | Drug | Diclofenac - Metamizole, Metamizole - Diclofenac, Metamizole - Placebo, Placebo - Metamizole |
| Metamizole placebo | Drug | Diclofenac - Metamizole, Metamizole - Diclofenac, Metamizole - Placebo, Placebo - Metamizole |
Primary outcome
Change in morphine requirement
Time frame: Baseline, 9 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metamizole and Diclofenac in people with Pain, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in morphine requirement (time frame: Baseline, 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.