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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

Last updated on May 10, 2018

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.
Show details

- 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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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: Celecoxib 200 milligrams
    Celecoxib 200 milligrams once a day
  • Drug: Celecoxib 400 milligrams
    Celecoxib 400 milligrams once a day
  • Drug: diclofenac 50 milligrams
    diclofenac 50 milligrams three times a day
  • Active Comparator: Celecoxib 200 milligrams mg QD
    celecoxib 200 milligrams (mg) once a day (QD)
    Intervention: Drug: Celecoxib 200 milligrams
  • Active Comparator: Celexocib 400 mg QD
    celecoxib 400 milligrams (mg) once a day (QD)
    Intervention: Drug: Celecoxib 400 milligrams
  • Active Comparator: Diclofenac 50 mg TID
    diclofenac 50 milligrams (mg) three times a day (TID)
    Intervention: Drug: diclofenac 50 milligrams
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
November 2004
November 2004   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT02528201
COXA-0508-247
A3191099 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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