Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A3191099 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400 milligrams (mg) once daily compared to diclofenac three times daily in the treatment of Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior 6 week trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib 200 milligrams mg QD | Active Comparator | celecoxib 200 milligrams (mg) once a day (QD) |
|
| Celexocib 400 mg QD | Active Comparator | celecoxib 400 milligrams (mg) once a day (QD) |
|
| Diclofenac 50 mg TID | Active Comparator | diclofenac 50 milligrams (mg) three times a day (TID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 200 milligrams | Drug | Celecoxib 200 milligrams once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12 | Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Global Assessment of Pain Intensity (VAS) | Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain. | Weeks 2, 6 |
| Bath Ankylosing Spondylitis Functional Index (BASFI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålesund sykehus | Ålesund | 6026 | Norway | |||
| Bekkestua legesenter |
Not provided
Not provided
Not provided
Not provided
Not provided
| Celecoxib 400 milligrams |
| Drug |
Celecoxib 400 milligrams once a day |
|
| diclofenac 50 milligrams | Drug | diclofenac 50 milligrams three times a day |
|
BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions. |
| Weeks 2, 6 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10 | Weeks 2, 6 |
| Participants and Physicians Global Assessment of Disease Activity | Participants are asked at each visit the following questions: Taking everything into account how do you assess the activity of your disease in the last 2 days on a scale where: 0=disease inactive with no symptoms and 100=disease extremely active? | Weeks 2, 6, 12 |
| Participants and Physicians Global Assessment of Treatment | The patients will be asked up to four global questions about safety and efficacy of the trial medication and about their current disease status. Responses are done on a 5 point scale where 0=no effect, 1=poor effect, 2=moderate effect, 3=good effect, and 4=excellent. At the same visits the investigator will be asked to do his/her own judgment of the efficacy and tolerance of the treatment (excellent, good, moderate, poor). | Week 12 |
| Participants Consumption of Rescue Medication | Participant consumption of rescue medication (paracetamol) calculated at each individual visit (except from the screening visit) by counting returned tablets versus tablets dispensed at the previous visit. | Baseline, Weeks 2, 6, 12 |
| Bekkestua |
| 1357 |
| Norway |
| Dr. Johannessen Kontor | Bergen | 5004 | Norway |
| Dr.Wiigs kontor | Bergen | 5838 | Norway |
| Nordland Medisinske Senter | Bodø | 8006 | Norway |
| Martina Hansens hospital | Bærum Postterminal | 1306 | Norway |
| Sykehuset Buskerud HF | Drammen | 3004 | Norway |
| Lægene på Kongens torv | Gamle Fredrikstad | 1632 | Norway |
| Centre For Clinical Trials | Hamar | 2300 | Norway |
| Harstad sykehus | Harstad | 9480 | Norway |
| Haugesund sanitetsforenings revmatismesykehus | Haugesund | 5513 | Norway |
| Horten legesenter | Horten | 3188 | Norway |
| Solli Klinikk AS | Jessheim | 2050 | Norway |
| Kongsvinger sykehus HF | Kongsvinger | 2226 | Norway |
| Vest-Agder sentralsykehus | Kristiansand | 4604 | Norway |
| Dr. Svensens kontor | Kristiansand | 4610 | Norway |
| Lensbygda Legekontor | Lena | 2850 | Norway |
| Helse Nord-Trøndelag HF, Sykehuset Levanger | Levanger | 7600 | Norway |
| LSF Reumatismesykehus | Lillehammer | 2609 | Norway |
| Helgelandssykehuset HF | Mo i Rana | 8607 | Norway |
| Rikshospitalet | Oslo | 0027 | Norway |
| Økernlegene | Oslo | 0580 | Norway |
| Diakonhjemmet Hospital | Oslo | N-0319 | Norway |
| Betanien Hospital | Skien | 3722 | Norway |
| Rosten legesenter | Tiller | 7092 | Norway |
| Universitetssykehuset Nord-Norge HF | Tromsø | 9038 | Norway |
| St.Olavs Hospital | Trondheim | 7006 | Norway |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided