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Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00163241
Collaborator
(none)
666
Enrollment
130
Locations
19
Duration (Months)
5.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
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
Study Start Date :
Jun 1, 2004
Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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.

  • 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.

Exclusion Criteria:

  • 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

  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 1L7
2 Pfizer Investigational Site Kitchener Ontario Canada N2M 5N6
3 Pfizer Investigational Site London Ontario Canada N6A 4V2
4 Pfizer Investigational Site Newmarket Ontario Canada L3Y 3R7
5 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
6 Pfizer Investigational Site Sainte-Foy Quebec Canada G1V 3M7
7 Pfizer Investigational Site Sainte-foy Quebec Canada G1V 4G2
8 Pfizer Investigational Site Trois-Revieres Quebec Canada G8Z 1Y2
9 Pfizer Investigational Site St. John's Canada A1C 5B8
10 Pfizer Investigational Site Angers France 49100
11 Pfizer Investigational Site Antibes France 06600
12 Pfizer Investigational Site Arles France 13200
13 Pfizer Investigational Site Avignon France 84000
14 Pfizer Investigational Site Bagnols Sur Ceze France 30200
15 Pfizer Investigational Site Beauvais France 6000
16 Pfizer Investigational Site Belfort France 90000
17 Pfizer Investigational Site Boulogne Sur Mer France 62200
18 Pfizer Investigational Site Caen France 14000
19 Pfizer Investigational Site Cahors France 46000
20 Pfizer Investigational Site Cannes La Boca France 06150
21 Pfizer Investigational Site Castelnaudary France 11400
22 Pfizer Investigational Site Chateuauroux France 36000
23 Pfizer Investigational Site Chaumont France 52100
24 Pfizer Investigational Site Cherbourg France 50100
25 Pfizer Investigational Site Clamart France 92140
26 Pfizer Investigational Site Clichy France 92110
27 Pfizer Investigational Site Colmar France 68000
28 Pfizer Investigational Site Corbeil Essonnes France 91100
29 Pfizer Investigational Site Cornebarrieu France 31700
30 Pfizer Investigational Site Courbevoie France 92200
31 Pfizer Investigational Site Creteil France 94000
32 Pfizer Investigational Site Dax France 40100
33 Pfizer Investigational Site Digne Les Bains France 04000
34 Pfizer Investigational Site Dijon France 21000
35 Pfizer Investigational Site Epernay France 51200
36 Pfizer Investigational Site Firminy France 42700
37 Pfizer Investigational Site Fontainebleau France 77300
38 Pfizer Investigational Site Gardanne France 13120
39 Pfizer Investigational Site Gonesse France 95500
40 Pfizer Investigational Site Grenoble France 38000
41 Pfizer Investigational Site Issy Les Moulineaux France 92130
42 Pfizer Investigational Site Ivry Sur Seine France 94200
43 Pfizer Investigational Site Jonzac France 17500
44 Pfizer Investigational Site Joue Les Tours France 37300
45 Pfizer Investigational Site L'Aigle France 61300
46 Pfizer Investigational Site L'union France 31240
47 Pfizer Investigational Site La Celle Saint Cloud France 78170
48 Pfizer Investigational Site La Rochelle France 17000
49 Pfizer Investigational Site Landivisiau France 29400
50 Pfizer Investigational Site Langon France 33210
51 Pfizer Investigational Site Laval Cedex France 53015
52 Pfizer Investigational Site Le Perreus Sur Marne France 94000
53 Pfizer Investigational Site Les Angles France 30133
54 Pfizer Investigational Site Libourne Cedex France 333505
55 Pfizer Investigational Site Limoges France 87042
56 Pfizer Investigational Site Lisieux France 14100
57 Pfizer Investigational Site Lunel France 34400
58 Pfizer Investigational Site Lyon France 69002
59 Pfizer Investigational Site Lyon France 69003
60 Pfizer Investigational Site Lyon France 69006
61 Pfizer Investigational Site Lyon France 69007
62 Pfizer Investigational Site Maisons Alfort France 94700
63 Pfizer Investigational Site Marseille Cedex 05 France 13354
64 Pfizer Investigational Site Marseille France 13008
65 Pfizer Investigational Site Marseille France 13015
66 Pfizer Investigational Site Martigues France 13500
67 Pfizer Investigational Site Montgeron France 91230
68 Pfizer Investigational Site Montigny le Bretonneux France 78180
69 Pfizer Investigational Site Montlucon France 03100
70 Pfizer Investigational Site Montpellier France 34070
71 Pfizer Investigational Site Montpellier France 34100
72 Pfizer Investigational Site Montpellier France 34295
73 Pfizer Investigational Site Moulins France 03000
74 Pfizer Investigational Site Nancy France 54000
75 Pfizer Investigational Site Nantes France 44000
76 Pfizer Investigational Site Neufchateau France 88300
77 Pfizer Investigational Site Nevers France 58000
78 Pfizer Investigational Site Nice France 06000
79 Pfizer Investigational Site Nimes France 30900
80 Pfizer Investigational Site Nogent le Rotrou France 28400
81 Pfizer Investigational Site Nosel France 77186
82 Pfizer Investigational Site Obernai France 67210
83 Pfizer Investigational Site Orleans Cedex 01 France 45000
84 Pfizer Investigational Site Orleans Cedex 01 France 45032
85 Pfizer Investigational Site Orly France 94310
86 Pfizer Investigational Site Ormesson Sur Marne France 94490
87 Pfizer Investigational Site Orthez France 64300
88 Pfizer Investigational Site Paris Cedex 12 France 75571
89 Pfizer Investigational Site Paris France 75011
90 Pfizer Investigational Site Paris France 75015
91 Pfizer Investigational Site Paris France 75017
92 Pfizer Investigational Site Paris France 75018
93 Pfizer Investigational Site Paris France 75020
94 Pfizer Investigational Site Petit Quevilly France 76140
95 Pfizer Investigational Site Poitiers France 86000
96 Pfizer Investigational Site Puteaux France 92800
97 Pfizer Investigational Site Quimper France 29000
98 Pfizer Investigational Site Reims France 51100
99 Pfizer Investigational Site Rennes France 1584
100 Pfizer Investigational Site Rennes France 35000
101 Pfizer Investigational Site Rodez France 12000
102 Pfizer Investigational Site Saint Afrique France 12400
103 Pfizer Investigational Site Saint Etienne France 42000
104 Pfizer Investigational Site Saint Genevvieve Des Bois France 91700
105 Pfizer Investigational Site Saint Giron France 09200
106 Pfizer Investigational Site Saint Jacques de la Lande France 35136
107 Pfizer Investigational Site Saint Lo France 50000
108 Pfizer Investigational Site Saint Maxime France 83120
109 Pfizer Investigational Site Saint Quentin France 02100
110 Pfizer Investigational Site Sartrouville France 78500
111 Pfizer Investigational Site St. Pierre de Coutances France 50200
112 Pfizer Investigational Site Strasbourg France 67000
113 Pfizer Investigational Site Strasbourg France 67098
114 Pfizer Investigational Site Thionville France 57100
115 Pfizer Investigational Site Thonon Les Bains France 74200
116 Pfizer Investigational Site Toulouse France 31000
117 Pfizer Investigational Site Toulouse France 31054
118 Pfizer Investigational Site Toulouse France 31076
119 Pfizer Investigational Site Toulouse France 31400
120 Pfizer Investigational Site Toulouse France 31500
121 Pfizer Investigational Site Tourcoing France 59200
122 Pfizer Investigational Site Tours France 37000
123 Pfizer Investigational Site Valence France 26000
124 Pfizer Investigational Site Vandoeuvre les Nancy France 54500
125 Pfizer Investigational Site Vence France 06140
126 Pfizer Investigational Site Versailles France 78000
127 Pfizer Investigational Site Villeneuve sur Lot France 47310
128 Pfizer Investigational Site Villeurbanne France 69100
129 Pfizer Investigational Site Vitre France 35500
130 Pfizer Investigational Site Vitrolles France 13127

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00163241
Other Study ID Numbers:
  • A3191068
First Posted:
Sep 13, 2005
Last Update Posted:
Mar 3, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Celecoxib

Study Results

No Results Posted as of Mar 3, 2021