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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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Celecoxib 200 milligrams Drug: Celecoxib 400 milligrams Drug: diclofenac 50 milligrams Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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?

  5. 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).

  6. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 to 75 years of age, inclusive.
  • Clinical diagnosis of ankylosing spondylitis:
  • Willing to stop existing NSAID/COX-2 inhibitor treatment for up to two weeks.
  • Having given written informed consent to participate in the trial.
  • Pain intensity ≥ 40 mm on the visual analog scale, worsening by at least 30 % compared to that recorded at the screening visit.
  • Last administration of analgesic without anti-inflammatory activity is ≥ 8 h, the last administration of long-acting NSAIDs is ≥ 72 h

Exclusion Criteria:

  • Patients with acute peripheral articular disease (defined by the onset within 4 weeks prior to visit
  • Known inflammatory enteropathy (e.g. ulcerative colitis, Crohn's disease).
  • Ongoing extra-articular signs (e.g. cardiac involvement).
  • Current painful vertebral compression.
  • Requirement to start physiotherapy, re-education or manipulation
  • History of clinical gastroduodenal ulcer in the year preceding inclusion, confirmed by endoscopy; continuing gastro-intestinal bleeding.
  • Cardiac failure or known renal insufficiency that could be affected by study medication, chronic or acute hepatic insufficiency, significant coagulation disorders or history of asthma.
  • Current or history of malignancy (except: patients having a basal cell carcinoma or other malignancy operated on and in remission for 5 years before inclusion in the trial).
  • Pregnancy, women of childbearing potential not using adequate contraceptive methods or nursing mothers.
  • Subject who has evidence of alcohol or drug abuse.
  • Participation in any other clinical study within 30 days prior to the screening visit.
  • Any condition that would prevent the patient from entering the study, according to the investigator's judgment.
  • Known hypersensitivity to celecoxib, sulphonamides or any NSAID (including salicylic acid).
  • Taking the following medications: Muscle relaxants, hypnotic, anxiolytics, sedatives, tranquillizers or antidepressants (unless stable for 2 weeks before screening and continuing throughout the trial), NSAIDs or COX-2 inhibitors other than study medication, acetylsalicylic acid (ASA) > 160 mg /day, anti-coagulants, ticlopidine, lithium, anti-TNF agents or methotrexate > 15 mg/week (Note: ASA ≤ 160 mg/day for cardioprotection is permitted), Use of oral or systemic analgesic medication, except from paracetamol, within 3 days of study entry and through the study, Corticosteroids (PO/IM/IV/IA) in the 6 weeks preceding inclusion in the trial, Anti-ulcer medication including chronic (daily or almost daily) use of antacids [Note: Occasional use of antacids during the study will be permitted.]
  • Change in dose of a slow-acting drug (e.g. sulfasalazin, methotrexate) in the past 60 days preceding inclusion in the trial.
  • Taking paracetamol > 2000 mg/day (including during the screening period).

Information from the National Library of Medicine

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


Locations
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Norway
Bekkestua legesenter
Bekkestua, Norway, 1357
Dr. Johannessen Kontor
Bergen, Norway, 5004
Dr.Wiigs kontor
Bergen, Norway, 5838
Nordland Medisinske Senter
Bodø, Norway, 8006
Martina Hansens hospital
Bærum Postterminal, Norway, 1306
Sykehuset Buskerud HF
Drammen, Norway, 3004
Lægene på Kongens torv
Gamle Fredrikstad, Norway, 1632
Centre For Clinical Trials
Hamar, Norway, 2300
Harstad sykehus
Harstad, Norway, 9480
Haugesund sanitetsforenings revmatismesykehus
Haugesund, Norway, 5513
Horten legesenter
Horten, Norway, 3188
Solli Klinikk AS
Jessheim, Norway, 2050
Kongsvinger sykehus HF
Kongsvinger, Norway, 2226
Vest-Agder sentralsykehus
Kristiansand, Norway, 4604
Dr. Svensens kontor
Kristiansand, Norway, 4610
Lensbygda Legekontor
Lena, Norway, 2850
Helse Nord-Trøndelag HF, Sykehuset Levanger
Levanger, Norway, 7600
LSF Reumatismesykehus
Lillehammer, Norway, 2609
Helgelandssykehuset HF
Mo I Rana, Norway, 8607
Rikshospitalet
Oslo, Norway, 0027
Økernlegene
Oslo, Norway, 0580
Diakonhjemmet Hospital
Oslo, Norway, N-0319
Betanien Hospital
Skien, Norway, 3722
Rosten legesenter
Tiller, Norway, 7092
Universitetssykehuset Nord-Norge HF
Tromsø, Norway, 9038
St.Olavs Hospital
Trondheim, Norway, 7006
Ålesund sykehus
Ålesund, Norway, 6026
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02528201     History of Changes
Other Study ID Numbers: COXA-0508-247
A3191099 ( Other Identifier: Alias Study Number )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Pfizer:
Ankylosing Spondylitis
Celecoxib
Diclofenac
Additional relevant MeSH terms:
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Diclofenac
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action