Spondylitis, AnkylosingPhase 3NCT00648141
Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
A Phase 3 study testing Celecoxib and Diclofenac in people with Spondylitis, Ankylosing, run by Pfizer at 47 sites in Germany.
Trial summary
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Celecoxib and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 47 sitesGermany
- Study dates
- Jan 2003to Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
- Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days
Who cannot join
- Patients with inflammatory enterophathy, and with extra-articular manifestations
- Patients with known vertebral compression
- Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Germany47 sites
Pfizer Investigational Site
Aachen, 52064
Pfizer Investigational Site
Bad Aibling, 83043
Pfizer Investigational Site
Bad Iburg, 49186
Pfizer Investigational Site
Bad Münder am Deister, 31848
Pfizer Investigational Site
Berlin, 10559
Pfizer Investigational Site
Berlin, 10777
Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
Berlin, 12247
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Berlin, 14059
Pfizer Investigational Site
Berlin, D-10098
Pfizer Investigational Site
Bonn, 53179
Pfizer Investigational Site
Celle / OT Klein Hehlen, 29223
Pfizer Investigational Site
Chemnitz, 09130
Pfizer Investigational Site
Cologne, 51107
Pfizer Investigational Site
Darmstadt, 64295
Pfizer Investigational Site
Dresden
Pfizer Investigational Site
Düsseldorf, 40211
Pfizer Investigational Site
Elmshorn, 25335
Pfizer Investigational Site
Erlangen, 91056
Pfizer Investigational Site
Halle, 06128
Pfizer Investigational Site
Hanover, 30161
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Hildesheim, 31134
Pfizer Investigational Site
Hofheim, 65719
Pfizer Investigational Site
Hoyerswerda, 02977
Pfizer Investigational Site
Leipzig, 04107
Pfizer Investigational Site
Leverkusen, 51373
Pfizer Investigational Site
Magdeburg, 39104
Pfizer Investigational Site
Mannheim, 68165
Pfizer Investigational Site
München, 80336
Pfizer Investigational Site
Neubrandenburg, 17033
Pfizer Investigational Site
Oldenburg, 26121
Pfizer Investigational Site
Osnabrück, 49074
Pfizer Investigational Site
Pirna, 01796
Pfizer Investigational Site
Ratingen, D40882
Pfizer Investigational Site
Regensburg
Pfizer Investigational Site
Remscheid, 42897
Pfizer Investigational Site
Rheine, 48431
Pfizer Investigational Site
Rostock, 18059
Pfizer Investigational Site
Saarbrücken, 66111
Pfizer Investigational Site
Seesen, 38723
Pfizer Investigational Site
Surwold, 26903
Pfizer Investigational Site
Tübingen, 72076
Pfizer Investigational Site
Villingen-Schwenningen, 78054
Pfizer Investigational Site
Weener, 26826
Pfizer Investigational Site
Winsen, 21423
About this study
Official title: A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Celecoxib, Diclofenac
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
200 mg oral capsule once daily for 12 weeks
CelecoxibDrug
200 mg oral capsule twice daily for 12 weeks
DiclofenacDrug
75 mg oral capsule twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Celecoxib |
| B | Experimental | Not described Receives: Drug: Celecoxib |
| C | Active comparator | Not described Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
Measured: Week 12
Responder rates, defined as 50% improvement in VAS from baseline
Measured: Week 12
Secondary outcomes (15)
Patient's and physician's global assessment of disease activity
Measured: Weeks 1, 2, 6, and 12
Spinal pain
Measured: Weeks 1, 2, 6, and 12
Short Form-12
Measured: Weeks 1, 2, 6, and 12
Adverse events
Measured: Week 12
Physical evaluation
Measured: Week 12
Laboratory tests
Measured: Week 12
Nocturnal pain
Measured: Weeks 1, 2, 6, and 12
Composite Bath Ankylosing Spondylitis Disease Activity Index
Measured: Weeks 1, 2, 6, and 12
Bath Ankylosing Spondylitis Metrology Index
Measured: Weeks 1, 2, 6, and 12
Change from baseline in C-reactive protein measurement
Measured: Week 12
Responder rates, defined as 50% improvement in VAS from baseline
Measured: Weeks 1, 2, and 6
Mobility parameters
Measured: Weeks 1, 2, 6, and 12
Change from baseline in Assessments in Ankylosing Spondylitis 20 score
Measured: Weeks 1, 2, 6, and 12
Change from baseline in global pain intensity
Measured: Weeks 1, 2, and 6
Bath Ankylosing Spondylitis Functional Index
Measured: Weeks 1, 2, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648141
- Sponsor's protocol ID
- COXA-0508-243
- Other IDs
- A3191098
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00648141
- Acronym / sponsor ID
- COXA-0508-243
- Conditions
- Spondylitis, Ankylosing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 1 Apr 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.
To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celecoxib |
| B | Experimental | Drug: Celecoxib |
| C | Active comparator | Drug: Diclofenac |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
- Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days
Key exclusion criteria (3 listed)
- Patients with inflammatory enterophathy, and with extra-articular manifestations
- Patients with known vertebral compression
- Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted
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 |
|---|---|---|
| Celecoxib200 mg oral capsule once daily for 12 weeks | Drug | A |
| Celecoxib200 mg oral capsule twice daily for 12 weeks | Drug | B |
| Diclofenac75 mg oral capsule twice daily for 12 weeks | Drug | C |
Primary outcome
Change from baseline in global pain intensity as assessed by visual analog scale (VAS)
Time frame: Week 12
Responder rates, defined as 50% improvement in VAS from baseline
Time frame: Week 12
15 secondary outcomes
Patient's and physician's global assessment of disease activity
Time frame: Weeks 1, 2, 6, and 12
Spinal pain
Time frame: Weeks 1, 2, 6, and 12
Short Form-12
Time frame: Weeks 1, 2, 6, and 12
Adverse events
Time frame: Week 12
Physical evaluation
Time frame: Week 12
Laboratory tests
Time frame: Week 12
Nocturnal pain
Time frame: Weeks 1, 2, 6, and 12
Composite Bath Ankylosing Spondylitis Disease Activity Index
Time frame: Weeks 1, 2, 6, and 12
Bath Ankylosing Spondylitis Metrology Index
Time frame: Weeks 1, 2, 6, and 12
Change from baseline in C-reactive protein measurement
Time frame: Week 12
Responder rates, defined as 50% improvement in VAS from baseline
Time frame: Weeks 1, 2, and 6
Mobility parameters
Time frame: Weeks 1, 2, 6, and 12
Change from baseline in Assessments in Ankylosing Spondylitis 20 score
Time frame: Weeks 1, 2, 6, and 12
Change from baseline in global pain intensity
Time frame: Weeks 1, 2, and 6
Bath Ankylosing Spondylitis Functional Index
Time frame: Weeks 1, 2, 6, and 12
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 10 Apr 2008.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib and Diclofenac in people with Spondylitis, Ankylosing, run by Pfizer at 47 sites 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 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites 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?
Change from baseline in global pain intensity as assessed by visual analog scale (VAS) (time frame: Week 12). 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?
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 10 Apr 2008.