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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Bekkestua legesenter
Bekkestua, , 1357 Norway
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT02528201
Pfizer
Completed
A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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