A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
NCT02528201
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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
- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis | |||
Official Title ICMJE | A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Ankylosing Spondylitis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 330 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2004 | |||
Actual Primary Completion Date | November 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Norway | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02528201 | |||
Other Study ID Numbers ICMJE | COXA-0508-247 A3191099 ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |