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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Celecoxib 200 milligrams (Drug); Celecoxib 400 milligrams (Drug); diclofenac 50 milligrams (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12

Secondary outcome:

Participants Global Assessment of Pain Intensity (VAS)

Bath Ankylosing Spondylitis Functional Index (BASFI)

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Participants and Physicians Global Assessment of Disease Activity

Participants and Physicians Global Assessment of Treatment

Participants Consumption of Rescue Medication


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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


- 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).

Locations and Contacts

Bekkestua legesenter, 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

Dr. Svensens kontor, Kristiansand 4610, Norway

Vest-Agder sentralsykehus, Kristiansand 4604, 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

Diakonhjemmet Hospital, Oslo N-0319, Norway

Rikshospitalet, Oslo 0027, Norway

Økernlegene, Oslo 0580, Norway

Betanien Hospital, Skien 3722, Norway

Rosten legesenter, Tiller 7092, Norway

Universitetssykehuset Nord-Norge HF, Tromsø 9038, Norway

St.Olavs Hospital, Trondheim 7006, Norway

Ålesund sykehus, Ålesund 6026, Norway

Additional Information

Starting date: September 2002
Last updated: August 18, 2015

Page last updated: August 23, 2015

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