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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Celecoxib 200 milligrams once a day
Celecoxib 400 milligrams once a day
diclofenac 50 milligrams three times a day
Ålesund sykehus
Ålesund, Norway
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.
Time frame: Baseline, Week 12
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.
Time frame: Weeks 2, 6
Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Time frame: 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
Time frame: 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?
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bekkestua legesenter
Bekkestua, Norway
Dr. Johannessen Kontor
Bergen, Norway
Dr.Wiigs kontor
Bergen, Norway
Nordland Medisinske Senter
Bodø, Norway
Martina Hansens hospital
Bærum Postterminal, Norway
Sykehuset Buskerud HF
Drammen, Norway
Lægene på Kongens torv
Gamle Fredrikstad, Norway
Centre For Clinical Trials
Hamar, Norway
Harstad sykehus
Harstad, Norway
...and 17 more locations
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Weeks 2, 6, 12