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OsteoarthritisPhase 3NCT00163241

Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

A Phase 3 study testing celecoxib in people with Osteoarthritis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 130 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Objectives of the study: Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered once daily (QD) for 24 months in slowing disease progression as assessed radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability of a continuous treatment… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
celecoxib
How many people
666 participants
Where
130 sitesin 2 countries
Study dates
Jun 2004to Jan 2006
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is 50 years of age or older.
  • If the subject is a female and of childbearing potential, or less than 2 years post-menopausal, she must have been using adequate contraception during her last menses and will use adequate contraception during the study, is not lactating, and has had a negative urine pregnancy test within 24 hours prior to receiving the first dose of study medication. Women less than two years post-menopausal are considered of childbearing potential for the purposes of this study.
  • The subject is diagnosed as having OA of the hip as defined by the American College of Rheumatology (ACR) criteria (see Appendix B)
  • The subject has symptomatic OA, as defined by the presence of daily hip pain for at least 1 month (not necessarily continuously) during the 2 months prior to screening visit.
  • The subject has hip pain of > or equal to 3 and < or equal to 9 on a 10-point Visual Numerical Scale (VNS) in the index hip.
  • Subjects with OA of the knee associated with OA of the hip will be included provided knee OA pain intensity is inferior to hip's one and no knee surgery is expected during the study.
Show all 9Show fewer
  • Subjects are functional class I, II or III according to the Steinbrocker criteria (see Appendix C).
  • The subject is eligible for pharmacologic treatment to control arthritis symptoms.
  • The subject has provided written informed consent before undergoing any study procedures.

Who cannot join

  • Bilateral hip OA with contralateral hip more severe symptomatically or radiologically than the index hip.
  • The subject has evidence of secondary hip OA.
  • Septic arthritis
  • Systemic or local inflammatory joint disease (e.g. psoriatic arthritis, spondylarthropathy, systemic lupus erythematosus, etc.)
  • Gout
  • Recurrent episode of pseudogout
Show all 39Show fewer
  • Paget's disease
  • Articular fracture
  • Ochronosis
  • Acromegaly
  • Haemochromatosis
  • Wilson's disease
  • Primary osteochondromatosis
  • Osteonecrosis
  • Slipped Capital Femoral Epiphysis (SCFE)
  • The subject has a concomitant inflammatory rheumatic condition, which may interfere with the assessment of OA, or acute joint trauma at the index hip.
  • The subject has received oral, intramuscular, intravenous, or soft tissue injection of corticosteroids within 4 weeks prior to the screening visit.
  • The subject has received an intra-articular injection of corticosteroids or hyaluronic acid in the index hip within 12 weeks prior to the screening visit.
  • The subject has received diacerein, chondroitin sulfate, glucosamine sulfate, doxycycline or avocado/soybean unsaponifiables within 12 weeks prior to the screening visit.
  • Arthroscopy or a corrective surgery of the index hip has been performed.
  • Arthroscopy or a corrective surgery of the contralateral hip has been performed within the 6 months prior to the screening visit .
  • Total replacement of the contralateral hip joint was performed within 6 months prior to the screening visit.
  • The subject is felt to require hip arthroplasty by the investigator at screening visit.
  • The subject has an active malignancy of any type. Subjects who have a history of basal cell carcinoma that has been successfully treated are acceptable. Subjects with a history of other malignancies that have been successfully treated and who have no evidence of recurrence for at least 5 years before study are also acceptable.
  • The subject has been diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to the screening visit.
  • The subject has a history of recurrent ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude use of NSAIDs.
  • The subject has a history of intolerance to paracetamol, opioids and tramadol such that it is felt that an adequate non-anti-inflammatory rescue analgesic regimen cannot be safely prescribed, or has a history of alcohol or substance abuse.
  • The subject has known hypersensitivity to celecoxib, demonstrated allergic-type reactions to sulfonamides, experienced asthma, urticaria or allergic-type reactions after taking sulfonamides, aspirin (acetylsalicylic acid [ASA]), lactose or NSAIDs.
  • The subject has been diagnosed as having or has been treated for gastrointestinal bleeding within 30 days before the screening visit.
  • The subject has previously been admitted to this study.
  • The subject has a likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (see Section 9 "Concomitant therapy").
  • The subject has severe disease, likely to jeopardize the planned completion of the study
  • The subject has abnormal baseline findings and or any other condition, which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  • The subject is not literate in French nor English or is unable according to the investigator to answer questions.
  • The subject has received any investigational drug within 30 days prior to the screening visit.
  • The subject has a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
  • The subject has congestive heart failure (Class II-IV).
  • The subject is using aspirin, including low dose aspirin.
  • The subject is using other antiplatelet agents (ticlopidine, clopidogrel, dipyridamole).

Trial locations and contacts

130 sites in 2 countries.

130 sites in 2 countries

France121 sites

  • Pfizer Investigational Site

    Angers, 49100

  • Pfizer Investigational Site

    Antibes, 06600

  • Pfizer Investigational Site

    Arles, 13200

  • Pfizer Investigational Site

    Avignon, 84000

  • Pfizer Investigational Site

    Bagnols-sur-Cèze, 30200

  • Pfizer Investigational Site

    Beauvais, 6000

  • Pfizer Investigational Site

    Belfort, 90000

  • Pfizer Investigational Site

    Boulogne-sur-Mer, 62200

  • Pfizer Investigational Site

    Caen, 14000

  • Pfizer Investigational Site

    Cahors, 46000

  • Pfizer Investigational Site

    Cannes La Boca, 06150

  • Pfizer Investigational Site

    Castelnaudary, 11400

  • Pfizer Investigational Site

    Chateuauroux, 36000

  • Pfizer Investigational Site

    Chaumont, 52100

  • Pfizer Investigational Site

    Cherbourg, 50100

  • Pfizer Investigational Site

    Clamart, 92140

  • Pfizer Investigational Site

    Clichy, 92110

  • Pfizer Investigational Site

    Colmar, 68000

  • Pfizer Investigational Site

    Corbeil-Essonnes, 91100

  • Pfizer Investigational Site

    Cornebarrieu, 31700

  • Pfizer Investigational Site

    Courbevoie, 92200

  • Pfizer Investigational Site

    Créteil, 94000

  • Pfizer Investigational Site

    Dax, 40100

  • Pfizer Investigational Site

    Digne-les-Bains, 04000

  • Pfizer Investigational Site

    Dijon, 21000

  • Pfizer Investigational Site

    Épernay, 51200

  • Pfizer Investigational Site

    Firminy, 42700

  • Pfizer Investigational Site

    Fontainebleau, 77300

  • Pfizer Investigational Site

    Gardanne, 13120

  • Pfizer Investigational Site

    Gonesse, 95500

  • Pfizer Investigational Site

    Grenoble, 38000

  • Pfizer Investigational Site

    Issy-les-Moulineaux, 92130

  • Pfizer Investigational Site

    Ivry-sur-Seine, 94200

  • Pfizer Investigational Site

    Jonzac, 17500

  • Pfizer Investigational Site

    Joué-lès-Tours, 37300

  • Pfizer Investigational Site

    L'Aigle, 61300

  • Pfizer Investigational Site

    L'Union, 31240

  • Pfizer Investigational Site

    La Celle-Saint-Cloud, 78170

  • Pfizer Investigational Site

    La Rochelle, 17000

  • Pfizer Investigational Site

    Landivisiau, 29400

  • Pfizer Investigational Site

    Langon, 33210

  • Pfizer Investigational Site

    Laval, 53015

  • Pfizer Investigational Site

    Le Perreus Sur Marne, 94000

  • Pfizer Investigational Site

    Le Petit-Quevilly, 76140

  • Pfizer Investigational Site

    Les Angles, 30133

  • Pfizer Investigational Site

    Libourne, 333505

  • Pfizer Investigational Site

    Limoges, 87042

  • Pfizer Investigational Site

    Lisieux, 14100

  • Pfizer Investigational Site

    Lunel, 34400

  • Pfizer Investigational Site

    Lyon, 69002

  • Pfizer Investigational Site

    Lyon, 69003

  • Pfizer Investigational Site

    Lyon, 69006

  • Pfizer Investigational Site

    Lyon, 69007

  • Pfizer Investigational Site

    Maisons-Alfort, 94700

  • Pfizer Investigational Site

    Marseille, 13008

  • Pfizer Investigational Site

    Marseille, 13015

  • Pfizer Investigational Site

    Marseille, 13354

  • Pfizer Investigational Site

    Martigues, 13500

  • Pfizer Investigational Site

    Montgeron, 91230

  • Pfizer Investigational Site

    Montigny-le-Bretonneux, 78180

  • Pfizer Investigational Site

    Montluçon, 03100

  • Pfizer Investigational Site

    Montpellier, 34070

  • Pfizer Investigational Site

    Montpellier, 34100

  • Pfizer Investigational Site

    Montpellier, 34295

  • Pfizer Investigational Site

    Moulins, 03000

  • Pfizer Investigational Site

    Nancy, 54000

  • Pfizer Investigational Site

    Nantes, 44000

  • Pfizer Investigational Site

    Naucelle, 77186

  • Pfizer Investigational Site

    Neufchâteau, 88300

  • Pfizer Investigational Site

    Nevers, 58000

  • Pfizer Investigational Site

    Nice, 06000

  • Pfizer Investigational Site

    Nîmes, 30900

  • Pfizer Investigational Site

    Nogent-le-Rotrou, 28400

  • Pfizer Investigational Site

    Obernai, 67210

  • Pfizer Investigational Site

    Orléans, 45000

  • Pfizer Investigational Site

    Orléans, 45032

  • Pfizer Investigational Site

    Orly, 94310

  • Pfizer Investigational Site

    Ormesson-sur-Marne, 94490

  • Pfizer Investigational Site

    Orthez, 64300

  • Pfizer Investigational Site

    Paris, 75011

  • Pfizer Investigational Site

    Paris, 75015

  • Pfizer Investigational Site

    Paris, 75017

  • Pfizer Investigational Site

    Paris, 75018

  • Pfizer Investigational Site

    Paris, 75020

  • Pfizer Investigational Site

    Paris, 75571

  • Pfizer Investigational Site

    Poitiers, 86000

  • Pfizer Investigational Site

    Puteaux, 92800

  • Pfizer Investigational Site

    Quimper, 29000

  • Pfizer Investigational Site

    Reims, 51100

  • Pfizer Investigational Site

    Rennes, 1584

  • Pfizer Investigational Site

    Rennes, 35000

  • Pfizer Investigational Site

    Rodez, 12000

  • Pfizer Investigational Site

    Saint Afrique, 12400

  • Pfizer Investigational Site

    Saint Genevvieve Des Bois, 91700

  • Pfizer Investigational Site

    Saint Giron, 09200

  • Pfizer Investigational Site

    Saint Maxime, 83120

  • Pfizer Investigational Site

    Saint-Etienne, 42000

  • Pfizer Investigational Site

    Saint-Jacques-de-la-Lande, 35136

  • Pfizer Investigational Site

    Saint-Lô, 50000

  • Pfizer Investigational Site

    Saint-Pierre-de-Coutances, 50200

  • Pfizer Investigational Site

    Saint-Quentin, 02100

  • Pfizer Investigational Site

    Sartrouville, 78500

  • Pfizer Investigational Site

    Strasbourg, 67000

  • Pfizer Investigational Site

    Strasbourg, 67098

  • Pfizer Investigational Site

    Thionville, 57100

  • Pfizer Investigational Site

    Thonon-les-Bains, 74200

  • Pfizer Investigational Site

    Toulouse, 31000

  • Pfizer Investigational Site

    Toulouse, 31054

  • Pfizer Investigational Site

    Toulouse, 31076

  • Pfizer Investigational Site

    Toulouse, 31400

  • Pfizer Investigational Site

    Toulouse, 31500

  • Pfizer Investigational Site

    Tourcoing, 59200

  • Pfizer Investigational Site

    Tours, 37000

  • Pfizer Investigational Site

    Valence, 26000

  • Pfizer Investigational Site

    Vandœuvre-lès-Nancy, 54500

  • Pfizer Investigational Site

    Vence, 06140

  • Pfizer Investigational Site

    Versailles, 78000

  • Pfizer Investigational Site

    Villeneuve-sur-Lot, 47310

  • Pfizer Investigational Site

    Villeurbanne, 69100

  • Pfizer Investigational Site

    Vitré, 35500

  • Pfizer Investigational Site

    Vitrolles, 13127

Other trials in France

Canada9 sites

  • Pfizer Investigational Site

    Kitchener, Ontario, N2M 5N6

  • Pfizer Investigational Site

    London, Ontario, N6A 4V2

  • Pfizer Investigational Site

    Montreal, Quebec, H2L 4M1

  • Pfizer Investigational Site

    Newmarket, Ontario, L3Y 3R7

  • Pfizer Investigational Site

    Sainte-Foy, Quebec, G1V 3M7

  • Pfizer Investigational Site

    Sainte-Foy, Quebec, G1V 4G2

  • Pfizer Investigational Site

    St. John's, A1C 5B8

  • Pfizer Investigational Site

    Trois-Revieres, Quebec, G8Z 1Y2

  • Pfizer Investigational Site

    Vancouver, British Columbia, V5Z 1L7

Other trials in Canada

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized 24-Month Study, Assessing The Effect Of Celecoxib (Celebrex) Long Term Treatment On Hip Osteoarthritis (OA) Progression OSCARE

Objectives of the study:

Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered once daily (QD) for 24 months in slowing disease progression as assessed radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects eligible for hip replacement according to the investigator.Evaluate the tolerability and safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with OA of the hip.

Read the detailed description

The study was terminated on 19 January 2006, prematurely, as a result of low enrollment Safety concerns did not lead to the decision to terminate this study.

Conditions
Osteoarthritis
Being tested
celecoxib
Medical subject headings
Osteoarthritis

What participants receive

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

What is being measured

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

  1. The primary efficacy endpoint is the change in the minimal JSW of the index hip during the 24-month follow up, compared to baseline. This endpoint will be expressed as the proportion of subjects achieving a 0.5 mm decrease in JSW on a radiograph and

Secondary outcomes (1)

  1. Number of days with rescue medication usage by drug category: paracetamol /paracetamol combination products, opioid/opioid combination products, celecoxib and other (e.g., propoxyphene) WOMAC subscales: pain and function (in comparison to baseline

Timeline

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

  1. First posted13 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Study completionJan 2006

Why it stopped: Please see detailed description for termination reason.

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
666 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00163241
Sponsor's protocol ID
A3191068
Status last verified
Mar 2021
First submitted
9 Sep 2005
Last updated
3 Mar 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing celecoxib in people with Osteoarthritis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 130 sites in 2 countries.

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 9 inclusion and 39 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: stopped early, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in France, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Please see detailed description for termination reason.). Results are not available in the source record.

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?

The primary efficacy endpoint is the change in the minimal JSW of the index hip during the 24-month follow up, compared to baseline. This endpoint will be expressed as the proportion of subjects achieving a 0.5 mm decrease in JSW on a radiograph and. 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 NCT00163241.

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 3 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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