Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

NCT00163241

Last updated date
Study Location
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1L7, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Randomized 24-Month Study, Assessing The Effect Of Celecoxib (Celebrex) Long Term Treatment On Hip Osteoarthritis (OA) Progression OSCARE
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Drug: celecoxib
Study Arms  ICMJE Not Provided
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 Terminated
Enrollment  ICMJE
 (submitted: September 9, 2005)
666
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Canada,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163241
Other Study ID Numbers  ICMJE A3191068
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP