OsteoarthritisPhase 3NCT00145301
52 Week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or Spine
A Phase 3 study testing Lumiracoxib in people with Osteoarthritis, run by Novartis at 1 site in Germany.
Trial summary
This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lumiracoxib
- How many people
- 3,036 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Nov 2005
- 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 40 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis in the hip, knee, hand, or spine
- Requiring NSAID therapy
Who cannot join
- Secondary OA with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient's OA pain assessment), and systemic lupus erythematosus
- History and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, Paget's disease of the bone, and articular fracture. If the patient has history of these conditions, then patient should only be excluded if the target joint is affected.
- History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 52-week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine
This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)
- Conditions
- Osteoarthritis
- Being tested
- Lumiracoxib
- Keywords
- Osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety
- 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 show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.
Secondary outcomes (4)
Safety & tolerability of pts using lumiracoxib vs pts using celecoxib
Efficacy of lumiracoxib vs celecoxib with respect to Patient's assessment of OA pain, Patient's global assessment of disease activity, and Physician's global assessment of disease activity
To compare reasons for discontinuation from treatment with lumiracoxib vs treatment with celecoxib
To validate the psychometric properties of the Short Arthritis assessment Scale (SAS) by analyzing pt reported outcomes collected in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionNov 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3,036 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145301
- Sponsor's protocol ID
- CCOX189A2369
- Status last verified
- May 2012
- First submitted
- 1 Sep 2005
- Last updated
- 21 May 2012
- Results posted
- No
Publications
Fleischmann R, Tannenbaum H, Patel NP, Notter M, Sallstig P, Reginster JY. Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis. BMC Musculoskelet Disord. 2008 Mar 7;9:32. doi: 10.1186/1471-2474-9-32.
PubMed 18328090
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 52-week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine
- ClinicalTrials.gov ID
- NCT00145301
- Acronym / sponsor ID
- CCOX189A2369
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,036 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Nov 2005 (actual)
- First posted
- 5 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 trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis in the hip, knee, hand, or spine
- Requiring NSAID therapy
Key exclusion criteria (4 listed)
- Secondary OA with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient's OA pain assessment), and systemic lupus erythematosus
- History and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, Paget's disease of the bone, and articular fracture. If the patient has history of these conditions, then patient should only be excluded if the target joint is affected.
- History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment.
- 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 show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.
4 secondary outcomes
Safety & tolerability of pts using lumiracoxib vs pts using celecoxib
Efficacy of lumiracoxib vs celecoxib with respect to Patient's assessment of OA pain, Patient's global assessment of disease activity, and Physician's global assessment of disease activity
To compare reasons for discontinuation from treatment with lumiracoxib vs treatment with celecoxib
To validate the psychometric properties of the Short Arthritis assessment Scale (SAS) by analyzing pt reported outcomes collected in this study
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.
- Derived from this study: PubMed 18328090Fleischmann R, Tannenbaum H, Patel NP, Notter M, Sallstig P, Reginster JY. Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis. BMC Musculoskelet Disord. 2008 Mar 7;9:32. doi: 10.1186/1471-2474-9-32.
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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.
1 site in 1 country: 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 1 site in Germany.
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 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 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 1 site in Germany. 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 show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.. 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 NCT00145301, 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 21 May 2012.