A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT02528201|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: Celecoxib 200 milligrams Drug: Celecoxib 400 milligrams Drug: diclofenac 50 milligrams||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||November 2004|
Active Comparator: Celecoxib 200 milligrams mg QD
celecoxib 200 milligrams (mg) once a day (QD)
Drug: Celecoxib 200 milligrams
Celecoxib 200 milligrams once a day
Active Comparator: Celexocib 400 mg QD
celecoxib 400 milligrams (mg) once a day (QD)
Drug: Celecoxib 400 milligrams
Celecoxib 400 milligrams once a day
Active Comparator: Diclofenac 50 mg TID
diclofenac 50 milligrams (mg) three times a day (TID)
Drug: diclofenac 50 milligrams
diclofenac 50 milligrams three times a day
- Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12 [ Time Frame: Baseline, 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.
- Participants Global Assessment of Pain Intensity (VAS) [ Time Frame: Weeks 2, 6 ]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.
- Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Weeks 2, 6 ]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.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Weeks 2, 6 ]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
- Participants and Physicians Global Assessment of Disease Activity [ Time Frame: Weeks 2, 6, 12 ]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?
- Participants and Physicians Global Assessment of Treatment [ Time Frame: Week 12 ]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).
- Participants Consumption of Rescue Medication [ Time Frame: Baseline, Weeks 2, 6, 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528201
|Study Director:||Pfizer CT.gov Call Center||Pfizer|