Acute GoutPhase 4NCT00142558
A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
A Phase 4 study testing MK0663; etoricoxib / Duration of Treatment: 5 Days and Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days in people with Acute Gout, run by Organon and Co.
Trial summary
A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gout
- What is being tested?
- MK0663; etoricoxib / Duration of Treatment: 5 Days and Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 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
- Males or females at least 18 years of age who have acute gout.
Who cannot join
None listed.
About this study
Official title: A Randomized, Double-Blind, Active-Comparator-Controlled 5-Day Trial of the Effect of Etoricoxib 120 mg Versus Indomethacin 150 mg in the Treatment of Acute Gout
A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.
- Conditions
- Acute Gout
- Being tested
- MK0663; etoricoxib / Duration of Treatment: 5 Days, Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days
- Keywords
- Arcoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663; etoricoxib / Duration of Treatment: 5 DaysDrug
Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient assessment of pain (0- to 4- Likert scale)
Secondary outcomes (4)
Patient Global Assessment of Response to Therapy (0- to 4- point scale)
Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
Tenderness of the study joint (0- to 3-point scale)
Swelling of the study joint (0- to 3-point scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study start1 Jan 2005
- Primary completion1 May 2005
- Study completion1 May 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute GoutStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
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
- NCT00142558
- Sponsor's protocol ID
- 0663-081
- Other IDs
- MK0663-081, 2005_062
- Status last verified
- Feb 2022
- First submitted
- 31 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91. doi: 10.1185/030079907x210750.
PubMed 17588299
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Comparator-Controlled 5-Day Trial of the Effect of Etoricoxib 120 mg Versus Indomethacin 150 mg in the Treatment of Acute Gout
- ClinicalTrials.gov ID
- NCT00142558
- Acronym / sponsor ID
- 0663-081
- Conditions
- Acute Gout
- Keywords
- Arcoxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 May 2005 (actual)
- Study completion
- 1 May 2005 (actual)
- First posted
- 2 Sep 2005 (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.
A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females at least 18 years of age who have acute gout.
Key exclusion criteria (0 listed)
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; etoricoxib / Duration of Treatment: 5 Days | Drug | – |
| Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days | Drug | – |
Primary outcome
Patient assessment of pain (0- to 4- Likert scale)
4 secondary outcomes
Patient Global Assessment of Response to Therapy (0- to 4- point scale)
Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
Tenderness of the study joint (0- to 3-point scale)
Swelling of the study joint (0- to 3-point scale)
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 15 Aug 2024.
- Derived from this study: PubMed 17588299Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91. doi: 10.1185/030079907x210750.
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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; etoricoxib / Duration of Treatment: 5 Days and Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days in people with Acute Gout, 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 1 inclusion and 0 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 15 Aug 2024. 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?
Patient assessment of pain (0- to 4- Likert scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142558, which also lists 1 linked publication.
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 15 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.