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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

Last updated on November 21, 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.
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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Descriptive Information
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 SummaryA 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 DescriptionNot 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
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: August 18, 2015)
330
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion DateNovember 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2015

ICMJE     Data element required by the

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

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

BY EMAIL

Contact

[email protected]

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