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Ankylosing SpondylitisPhase 4NCT02528201

A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

A Phase 4 study testing Celecoxib 200 milligrams, Celecoxib 400 milligrams and diclofenac 50 milligrams in people with Ankylosing Spondylitis, run by Pfizer at 27 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Celecoxib 200 milligrams, Celecoxib 400 milligrams and diclofenac 50 milligrams
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
27 sitesNorway
Study dates
Sep 2002to Nov 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Norway27 sites

  • Ålesund sykehus

    Ålesund, 6026

  • Martina Hansens hospital

    Bærum Postterminal, 1306

  • Bekkestua legesenter

    Bekkestua, 1357

  • Dr. Johannessen Kontor

    Bergen, 5004

  • Dr.Wiigs kontor

    Bergen, 5838

  • Nordland Medisinske Senter

    Bodø, 8006

  • Sykehuset Buskerud HF

    Drammen, 3004

  • Lægene på Kongens torv

    Gamle Fredrikstad, 1632

  • Centre For Clinical Trials

    Hamar, 2300

  • Harstad sykehus

    Harstad, 9480

  • Haugesund sanitetsforenings revmatismesykehus

    Haugesund, 5513

  • Horten legesenter

    Horten, 3188

  • Solli Klinikk AS

    Jessheim, 2050

  • Kongsvinger sykehus HF

    Kongsvinger, 2226

  • Vest-Agder sentralsykehus

    Kristiansand, 4604

  • Dr. Svensens kontor

    Kristiansand, 4610

  • Lensbygda Legekontor

    Lena, 2850

  • Helse Nord-Trøndelag HF, Sykehuset Levanger

    Levanger, 7600

  • LSF Reumatismesykehus

    Lillehammer, 2609

  • Helgelandssykehuset HF

    Mo i Rana, 8607

  • Rikshospitalet

    Oslo, 0027

  • Økernlegene

    Oslo, 0580

  • Diakonhjemmet Hospital

    Oslo, N-0319

  • Betanien Hospital

    Skien, 3722

  • Rosten legesenter

    Tiller, 7092

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9038

  • St.Olavs Hospital

    Trondheim, 7006

Other trials in Norway

About this study

Official title: 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.

Being tested
Celecoxib 200 milligrams, Celecoxib 400 milligrams, diclofenac 50 milligrams
Keywords
Ankylosing Spondylitis, Celecoxib, Diclofenac
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Celecoxib 200 milligramsDrug

    Celecoxib 200 milligrams once a day

  • Celecoxib 400 milligramsDrug

    Celecoxib 400 milligrams once a day

  • diclofenac 50 milligramsDrug

    diclofenac 50 milligrams three times a day

Study groups in NCT02528201
Study groupRoleWhat they receive
Celecoxib 200 milligrams mg QDActive comparatorcelecoxib 200 milligrams (mg) once a day (QD)
Receives: Drug: Celecoxib 200 milligrams
Celexocib 400 mg QDActive comparatorcelecoxib 400 milligrams (mg) once a day (QD)
Receives: Drug: Celecoxib 400 milligrams
Diclofenac 50 mg TIDActive comparatordiclofenac 50 milligrams (mg) three times a day (TID)
Receives: Drug: diclofenac 50 milligrams

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12

    Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain.

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. Participants Global Assessment of Pain Intensity (VAS)

    Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain.

    Measured: Weeks 2, 6

  2. Bath Ankylosing Spondylitis Functional Index (BASFI)

    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

    Measured: Weeks 2, 6

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10

    Measured: Weeks 2, 6

  4. Participants and Physicians Global Assessment of Disease Activity

    Participants are asked at each visit the following questions: Taking everything into account how do you assess the activity of your disease in the last 2 days on a scale where: 0=disease inactive with no symptoms and 100=disease extremely active?

    Measured: Weeks 2, 6, 12

  5. Participants and Physicians Global Assessment of Treatment

    The patients will be asked up to four global questions about safety and efficacy of the trial medication and about their current disease status. Responses are done on a 5 point scale where 0=no effect, 1=poor effect, 2=moderate effect, 3=good effect, and 4=excellent. At the same visits the investigator will be asked to do his/her own judgment of the efficacy and tolerance of the treatment (excellent, good, moderate, poor).

    Measured: Week 12

  6. Participants Consumption of Rescue Medication

    Participant consumption of rescue medication (paracetamol) calculated at each individual visit (except from the screening visit) by counting returned tablets versus tablets dispensed at the previous visit.

    Measured: Baseline, Weeks 2, 6, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startSep 2002
  3. Primary completionNov 2004
  4. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528201
Sponsor's protocol ID
COXA-0508-247
Other IDs
A3191099
Status last verified
Aug 2015
First submitted
18 Jun 2015
Last updated
19 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Celecoxib 200 milligrams, Celecoxib 400 milligrams and diclofenac 50 milligrams in people with Ankylosing Spondylitis, run by Pfizer at 27 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02528201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.

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