Osteoarthritis, HipPhase 3NCT00154219
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
A Phase 3 study testing Lumiracoxib (drug) in people with Osteoarthritis, Hip, run by Novartis at 5 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Lumiracoxib (drug)
- How many people
- 1,200 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Nov 2004to Oct 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary hip osteoarthritis
- Qualifying pain intensity in the hip joint
- Requiring NSAID therapy
Who cannot join
- Rheumatoid arthritis or other inflammatory joint disease
- Disease or disorder that may interfere with pain assessment of the hip
- Open knee/hip surgery within the last year
- Past history of heart attack, stroke or angina (chest pain)
- Liver disorder
- History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
For US Site Information, contact Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
- Conditions
- Osteoarthritis, Hip
- Being tested
- Lumiracoxib (drug)
- Keywords
- Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumiracoxib (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Secondary outcomes (5)
Overall OA pain intensity (VAS)by visit
Physician's global assessment of disease activity (VAS) by visit
Response to treatment according to OARSI criteria by visit
Actual OA pain intensity at 12 hours post-dose by visit
Number of rescue tablets taken during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionOct 2006
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 Osteoarthritis, HipStudies 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
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154219
- Sponsor's protocol ID
- CCOX189A2367
- Status last verified
- May 2012
- First submitted
- 7 Sep 2005
- Last updated
- 21 May 2012
- Results posted
- No
Publications
Schnitzer TJ, Dattani ID, Seriolo B, Schneider H, Moore A, Tseng L, Sallstig P, Rebuli R, Maxwell T. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol. 2011 Nov;30(11):1433-46. doi: 10.1007/s10067-011-1776-4. Epub 2011 May 24.
PubMed 21607551
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 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
- ClinicalTrials.gov ID
- NCT00154219
- Acronym / sponsor ID
- CCOX189A2367
- Conditions
- Osteoarthritis, Hip
- Keywords
- Osteoarthritis, Hip, Lumiracoxib, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Oct 2006 (actual)
- First posted
- 12 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.
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary hip osteoarthritis
- Qualifying pain intensity in the hip joint
- Requiring NSAID therapy
Key exclusion criteria (7 listed)
- Rheumatoid arthritis or other inflammatory joint disease
- Disease or disorder that may interfere with pain assessment of the hip
- Open knee/hip surgery within the last year
- Past history of heart attack, stroke or angina (chest pain)
- Liver disorder
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) | Drug | – |
Primary outcome
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
5 secondary outcomes
Overall OA pain intensity (VAS)by visit
Physician's global assessment of disease activity (VAS) by visit
Response to treatment according to OARSI criteria by visit
Actual OA pain intensity at 12 hours post-dose by visit
Number of rescue tablets taken during the 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 21607551Schnitzer TJ, Dattani ID, Seriolo B, Schneider H, Moore A, Tseng L, Sallstig P, Rebuli R, Maxwell T. A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis. Clin Rheumatol. 2011 Nov;30(11):1433-46. doi: 10.1007/s10067-011-1776-4. Epub 2011 May 24.
- Novartis patient recruitment websiteLink provided by the sponsor.
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumiracoxib (drug) in people with Osteoarthritis, Hip, run by Novartis at 5 sites in 5 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 7 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 5 sites in United States, Canada, Germany, Italy, United Kingdom. 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?
WOMAC 3.1 LK questionnaire after 13 weeks of treatment. The study lists 2 primary outcomes in all. 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 NCT00154219, 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.