Clinical trial NCT02528201: A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Celecoxib
Diclofenac
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-08-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Participants Global Assessment of Pain Intensity (VAS)
timeFrame: Weeks 2, 6
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Weeks 2, 6
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Weeks 2, 6
measure: Participants and Physicians Global Assessment of Disease Activity
timeFrame: Weeks 2, 6, 12
measure: Participants and Physicians Global Assessment of Treatment
timeFrame: Week 12
measure: Participants Consumption of Rescue Medication
timeFrame: Baseline, Weeks 2, 6, 12
Other outcomes:
Locations:
city: Bekkestua
country: Norway
facility: Bekkestua legesenter
city: Bergen
country: Norway
facility: Dr. Johannessen Kontor
city: Bergen
country: Norway
facility: Dr.Wiigs kontor
city: Bodø
country: Norway
facility: Nordland Medisinske Senter
city: Bærum Postterminal
country: Norway
facility: Martina Hansens hospital
city: Drammen
country: Norway
facility: Sykehuset Buskerud HF
city: Gamle Fredrikstad
country: Norway
facility: Lægene på Kongens torv
city: Hamar
country: Norway
facility: Centre For Clinical Trials
city: Harstad
country: Norway
facility: Harstad sykehus
city: Haugesund
country: Norway
facility: Haugesund sanitetsforenings revmatismesykehus
city: Horten
country: Norway
facility: Horten legesenter
city: Jessheim
country: Norway
facility: Solli Klinikk AS
city: Kongsvinger
country: Norway
facility: Kongsvinger sykehus HF
city: Kristiansand
country: Norway
facility: Vest-Agder sentralsykehus
city: Kristiansand
country: Norway
facility: Dr. Svensens kontor
city: Lena
country: Norway
facility: Lensbygda Legekontor
city: Levanger
country: Norway
facility: Helse Nord-Trøndelag HF, Sykehuset Levanger
city: Lillehammer
country: Norway
facility: LSF Reumatismesykehus
city: Mo I Rana
country: Norway
facility: Helgelandssykehuset HF
city: Oslo
country: Norway
facility: Rikshospitalet
city: Oslo
country: Norway
facility: Økernlegene
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Skien
country: Norway
facility: Betanien Hospital
city: Tiller
country: Norway
facility: Rosten legesenter
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge HF
city: Trondheim
country: Norway
facility: St.Olavs Hospital
city: Ålesund
country: Norway
facility: Ålesund sykehus
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: