OsteoarthritisPhase 3NCT00475800
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
A Phase 3 study testing Lumiracoxib in people with Osteoarthritis, run by Novartis at 6 sites in 2 countries.
Trial summary
This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lumiracoxib
- How many people
- 833 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2004to Dec 2004
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- Have completed the core CCOX189A2360 study
- Males and females over the 18 years old
Who cannot join
- Treatment in the extension study is not considered appropriate by the treating physician
- Non-compliance or major protocol violation of the core study
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Study site
Albuquerque, New Mexico, 87109
Study site
Brooklyn Park, Minnesota, 55430
Study site
San Antonio, Texas, 78232
Study site
Sioux Falls, South Dakota, 57105
Study site
Tucson, Arizona, 85723
About this study
Official title: A 39-week, Open-label Extension to CCOX189A2360, a 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.
- Conditions
- Osteoarthritis
- Being tested
- Lumiracoxib
- Keywords
- Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee
- Medical subject headings
- Osteoarthritis
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.
To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
Secondary outcomes (3)
Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
Patient's global assessment of disease activity by visit
Physician's global assessment of disease activity by visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJan 2004
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475800
- Sponsor's protocol ID
- CCOX189A2360E1
- Status last verified
- May 2012
- First submitted
- 18 May 2007
- Last updated
- 21 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 39-week, Open-label Extension to CCOX189A2360, a 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
- ClinicalTrials.gov ID
- NCT00475800
- Acronym / sponsor ID
- CCOX189A2360E1
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 21 May 2007 (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 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.
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
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have completed the core CCOX189A2360 study
- Males and females over the 18 years old
Key exclusion criteria (3 listed)
- Treatment in the extension study is not considered appropriate by the treating physician
- Non-compliance or major protocol violation of the core study
- 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
To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
3 secondary outcomes
Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
Patient's global assessment of disease activity by visit
Physician's global assessment of disease activity by visit.
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 21 May 2012.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumiracoxib in people with Osteoarthritis, run by Novartis at 6 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 2 inclusion and 3 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.. 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 21 May 2012.