Osteoarthritis, KneePhase 3NCT00366938
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
A Phase 3 study testing Lumiracoxib in people with Osteoarthritis, Knee, run by Novartis at 1 site in United States.
Trial summary
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Lumiracoxib
- How many people
- 1,464 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 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
- Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
- Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
Who cannot join
- Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
- Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, 07936
About this study
Official title: 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 study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Lumiracoxib
- Keywords
- Osteoarthritis, lumiracoxib, celecoxib, Cox-2
- Medical subject headings
- Osteoarthritis, Knee, 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.
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary outcomes (5)
Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Patient's health status using the Short Form-36 (SF-36), at week 13.
Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startSep 2003
- Primary completionMar 2004
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, KneeStudies 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
- 1,464 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366938
- Sponsor's protocol ID
- CCOX189A2360
- Status last verified
- May 2012
- First submitted
- 18 Aug 2006
- Last updated
- 21 May 2012
- Results posted
- No
Publications
Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.
PubMed 17266764
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 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
- NCT00366938
- Acronym / sponsor ID
- CCOX189A2360
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, lumiracoxib, celecoxib, Cox-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,464 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 22 Aug 2006 (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 will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
- Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
Key exclusion criteria (3 listed)
- Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
- Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
- 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
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
5 secondary outcomes
Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Patient's health status using the Short Form-36 (SF-36), at week 13.
Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
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 17266764Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.
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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 Pharmaceuticals study chair
Novartis
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, Knee, run by Novartis at 1 site in United States.
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 1 site in United States. 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?
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.. The study lists 3 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 NCT00366938, 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.