Acute Gouty ArthritisPhase 4NCT00170781
Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
A Phase 4 study testing Lumiracoxib in people with Acute Gouty Arthritis, run by Novartis at 2 sites in 2 countries.
Trial summary
This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gouty Arthritis
- What is being tested?
- Lumiracoxib
- How many people
- 234 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2005to not given
- 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
- Ambulatory cooperative male or female patients of at least 18 years of age
- With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
- Who present at Baseline with an acute pain intensity of at least moderate.
Who cannot join
- With an acute attack of gout before the last 48 hours prior to evaluation
- With polyarticular gout involving > 4 joints
- With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
For Site Information, contact Novartis Pharma AG
Basel, CH, 4002
About this study
Official title: A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)
This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy
- Conditions
- Acute Gouty Arthritis
- Being tested
- Lumiracoxib
- Keywords
- Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
- Medical subject headings
- Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiracoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Secondary outcomes (9)
Safety and tolerability profile
Pain intensity in the study joint over the entire treatment period
Patient's and Physician's global assessment of response to therapy
Physician's assessment of tenderness and swelling of study joint
C-reactive protein level
Proportion of patients who discontinued treatment because of a lack of efficacy
Usage of rescue medication
SF-36 and EQ-5D
Physician's assessment of erythema of study joint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gouty ArthritisStudies 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
- Enrolment
- 234 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharma AG, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170781
- Sponsor's protocol ID
- CCOX189A2426
- Status last verified
- Jun 2006
- First submitted
- 9 Sep 2005
- Last updated
- 30 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)
- ClinicalTrials.gov ID
- NCT00170781
- Acronym / sponsor ID
- CCOX189A2426
- Conditions
- Acute Gouty Arthritis
- Keywords
- Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 15 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.
This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory cooperative male or female patients of at least 18 years of age
- With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
- Who present at Baseline with an acute pain intensity of at least moderate.
Key exclusion criteria (4 listed)
- With an acute attack of gout before the last 48 hours prior to evaluation
- With polyarticular gout involving > 4 joints
- With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Lumiracoxib | Drug | – |
Primary outcome
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
9 secondary outcomes
Safety and tolerability profile
Pain intensity in the study joint over the entire treatment period
Patient's and Physician's global assessment of response to therapy
Physician's assessment of tenderness and swelling of study joint
C-reactive protein level
Proportion of patients who discontinued treatment because of a lack of efficacy
Usage of rescue medication
SF-36 and EQ-5D
Physician's assessment of erythema of study joint
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 30 Nov 2006.
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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.
Novartis Pharma AG study chair
Sponsor GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumiracoxib in people with Acute Gouty Arthritis, run by Novartis at 2 sites in 2 countries.
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 30 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose. 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 30 Nov 2006.