PainPhase 4NCT00380523
Analgesic Treatment Mediated by Arcoxia (0663-093)
A Phase 4 study testing MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days in people with Pain, run by Organon and Co.
Trial summary
Allow physicians to test the efficacy of arcoxia in patients with acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2005
- 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
- Diagnosis of acute pain susceptible of pharmacological treatment
- Greater than 18 years of age
- Voluntary acceptance to participate in the study and signature of the informed consent form
Who cannot join
- Allergy to etoricoxib or any of its components
- Less than 18 years old
- Patient is taking anticoagulants
- Patient that already has taken any drug as analgesic
About this study
Official title: Analgesic Treatment Mediated by Arcoxia
Allow physicians to test the efficacy of arcoxia in patients with acute pain.
- Conditions
- Pain
- Being tested
- MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three days)
Secondary outcomes (2)
Patient satisfaction with the drug therapy using PGART scale
Patient satisfaction was obtained at the end of treatment(on third day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startApr 2005
- Primary completionMay 2005
- Study completionMay 2005
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380523
- Sponsor's protocol ID
- 0663-093
- Other IDs
- 2006_034
- Status last verified
- Feb 2022
- First submitted
- 22 Sep 2006
- Last updated
- 16 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Treatment Mediated by Arcoxia
- ClinicalTrials.gov ID
- NCT00380523
- Acronym / sponsor ID
- 0663-093
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 26 Sep 2006 (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.
Allow physicians to test the efficacy of arcoxia in patients with acute pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute pain susceptible of pharmacological treatment
- Greater than 18 years of age
- Voluntary acceptance to participate in the study and signature of the informed consent form
Key exclusion criteria (4 listed)
- Allergy to etoricoxib or any of its components
- Less than 18 years old
- Patient is taking anticoagulants
- Patient that already has taken any drug as analgesic
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 |
|---|---|---|
| MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days | Drug | – |
Primary outcome
Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three days)
2 secondary outcomes
Patient satisfaction with the drug therapy using PGART scale
Patient satisfaction was obtained at the end of treatment(on third day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days in people with Pain, run by Organon and Co.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Feb 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three 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 16 Feb 2022.