OsteoarthritisPhase 3NCT00637949
Safety of Lumiracoxib in Patients With Osteoarthritis
A Phase 3 study testing lumiracoxib and rofecoxib in people with Osteoarthritis, run by Novartis.
Trial summary
This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- lumiracoxib and rofecoxib
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Mar 2001
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=50 years old
- Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
- Pain in the target joint of moderate intensity
- Written informed consent
Who cannot join
- Secondary osteoarthritis
- Active upper gastro intestinal tract ulceration
- Inflammatory joint disease
- Gout
- Clinically significant hepatic or renal disease
- Other in and exclusion criteria may apply
About this study
Official title: A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator
This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator
- Conditions
- Osteoarthritis
- Being tested
- lumiracoxib, rofecoxib
- Keywords
- Osteoarthritis, lumiracoxib, rofecoxib, Cox-2, Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumiracoxibDevice
Also called Prexige
400 mg once daily, oral over 6 weeks
rofecoxibDrug
Also called Vioxx
25 mg, oral, daily over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: lumiracoxib |
| 2 | Active comparator | Not described Receives: Drug: rofecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of at least one of seven predefined gastrointestinal adverse events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startDec 2000
- Primary completionMar 2001
- Study completionMar 2001
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
- Who is masked
- Participant, Investigator
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637949
- Sponsor's protocol ID
- CCOX189A2307
- Status last verified
- Mar 2008
- First submitted
- 11 Mar 2008
- Last updated
- 18 Mar 2008
- Results posted
- No
Publications
Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.
PubMed 18778469
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator
- ClinicalTrials.gov ID
- NCT00637949
- Acronym / sponsor ID
- CCOX189A2307
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, lumiracoxib, rofecoxib, Cox-2, Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Mar 2001 (actual)
- Study completion
- Mar 2001 (actual)
- First posted
- 18 Mar 2008 (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 safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: lumiracoxib |
| 2 | Active comparator | Drug: rofecoxib |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=50 years old
- Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
- Pain in the target joint of moderate intensity
- Written informed consent
Key exclusion criteria (6 listed)
- Secondary osteoarthritis
- Active upper gastro intestinal tract ulceration
- Inflammatory joint disease
- Gout
- Clinically significant hepatic or renal disease
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 |
|---|---|---|
| lumiracoxibAlso: Prexige400 mg once daily, oral over 6 weeks | Device | 1 |
| rofecoxibAlso: Vioxx25 mg, oral, daily over 6 weeks | Drug | 2 |
Primary outcome
Incidence of at least one of seven predefined gastrointestinal adverse events
Time frame: 6 weeks
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 18 Mar 2008.
- Derived from this study: PubMed 18778469Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lumiracoxib and rofecoxib in people with Osteoarthritis, run by Novartis.
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 4 inclusion and 6 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 18 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of at least one of seven predefined gastrointestinal adverse events (time frame: 6 weeks). 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 NCT00637949, 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 18 Mar 2008.