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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2009-013329-41-AT |
Date of registration:
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13/11/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip
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Scientific title:
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A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip |
Date of first enrolment:
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26/11/2009 |
Target sample size:
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800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013329-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Denmark
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France
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Germany
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Spain
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study. 1. Patients must consent in writing to participate in the study by signing and dating an Informed Consent Document indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the Screening procedures; 2. Male or female of any race, 18-75 years of age, inclusive; 3. Patients must have a diagnosis of OA of the knee or hip based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence24 x-ray grade of =2) X-rays taken within the last 12 months may be used for confirmation; 4. Patients must regularly use analgesic medication, defined as > 4 days per week for the last month prior to Screening. Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, opioids or combinations thereof. Acetaminophen cannot be the sole analgesic used; 5. At least one of the following three criteria must be met. • Non-opioid pain medications (eg, NSAIDs) or opioid medications at prescribed doses less than or equal to a morphine equivalent of 90 mg/day (oxycodone 60 mg/day) have not provided adequate pain relief or • Patient are unable to take non-opioid pain medications (eg, NSAIDs) or • Patients are candidates for or seeking invasive interventions such as intra-articular injections, knee or hip arthroplasty, or knee or hip replacement surgery; 6. WOMAC Pain subscale NRS =4 in the index knee or index hip at Screening with or without analgesic medication; 7. WOMAC Pain subscale NRS =5 in the index knee or index hip at Baseline; 8. An increase of =1 point in WOMAC Pain subscale NRS in the index knee or index hip from Screening to Baseline; 9. WOMAC Physical Function subscale NRS =4 in the index knee or index hip at Baseline; 10. Patient Global Assessment of Osteoarthritis must be “fair,” “poor,” or “very poor” at Baseline; 11. Patients must be willing to discontinue all pain medications for OA except rescue medication and not use prohibited pain medications throughout the duration of the study except as permitted per Protocol; 12. Female patients must meet one of the following criteria: a. Female patients of non-childbearing potential: • Must be post-menopausal, defined as women who are =45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle-Stimulating Hormone (FSH) level greater than 30 IU/L at Screening; or • Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy. b. Female patients of child-bearing potential: • Must not be pregnant or lactating; and • Must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method); and • Must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing. Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential. Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of screen
Exclusion criteria: 1. Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant 2. Body mass index (BMI) of >39 kg/m2 3. History of inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget’s disease, or tumors 4. Significant trauma or surgery to the index joint within the previous year; 5. Planned surgical procedure 6. Largely or wholly incapacitated 7. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy 8. Other pain that may confound assessments or self-evaluation of pain 9. History of cancer within the last 5yrs 10. Signs and symptoms of clinically significant cardiac disease including but not limited to •Ischemic cardiac disease •Surgery or stent placement for coronary artery disease in the 6 months prior to Screening •New York Heart Association (NYHA) Class III or IV congestive heart failure or known left ventricular dysfunction with ejection fraction =35%, cardiomyopathy, myocarditis in the 6 months prior to Screening •Resting tachycardia (heart rate =120) or resting bradycardia (heart rate =45) on ECG at Screening or Baseline •QTc interval >500 msec in the absence of bundle branch block or paced rhythm •Any CV illness that would render a patient unsuitable to participate 11. Diagnosis of a transient ischemic attack in the 6 months or diagnosis of stroke with residual deficits (eg, aphasia, substantial motor or sensory deficits) 12. History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to •Alzheimer’s disease or other types of dementia •Clinically significant head trauma within the past year •Peripheral neuropathy •Multiple sclerosis •Epilepsy or seizure •Myopathy 13. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder, including but not limited to •Psychotic disorders •Somatoform disorders •Bipolar disorders •Any other psychiatric illness that would render a patient unsuitable 14. Hospital admission for depression or suicide attempt within 5 years of Screening or active, severe major depression at Screening 15. History of known alcohol, analgesic or non-narcotic drug abuse within 2 years 16. Any history of known opioid or narcotic abuse 17. Previous exposure to exogenous NGF or to an anti-NGF antibody 18. Exposure to opioids at doses exceeding a morphine equivalent of 90 mg/day (oxycodone 60 mg/day) within 30 days prior to Screening is exclusionary 19. Use of any analgesic from Screening to the start of the Initial Pain Assessment Period (the 3 days prior to Randomization/Baseline) without a sufficient washout 20. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein 21. History of intolerance or hypersensitivity to paracetamol or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated 22. History of intolerance or hypersensitivity to oxycodone or any of its excipients 23. Patients taking >325 mg/day of aspirin (or any salicylate containing medications). 24. Existence of a medical condition for which the use of oxycodone is contraindicated 25. Resting, sitting blood pressure (BP) =160 mm Hg in systolic pressure or =100 mm Hg or diastolic blood
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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osteoarthritis of the knee and hip MedDRA version: 12.0
Level: LLT
Classification code 10020108
Term: Hips osteoarthritis
MedDRA version: 12.0
Level: LLT
Classification code 10023476
Term: Knee osteoarthritis
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Intervention(s)
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Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for infusion INN or Proposed INN: tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for infusion INN or Proposed INN: tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Trade Name: OxyContin Pharmaceutical Form: Capsule* INN or Proposed INN: OXYCODONE CAS Number: 76426 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: • Demonstrate superior analgesic efficacy of tanezumab 10 mg and 5 mg administered IV every 8 weeks compared to placebo at Week 16. • Demonstrate non-inferiority and, if warranted, superior analgesic efficacy of tanezumab 10 mg and 5 mg administered IV every 8 weeks compared to oxycodone HCl controlled release (CR) tablets (Oxycontin) 10-40 mg every 12 hours (q12h) at Week 16.
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Primary end point(s): - The primary endpoint for the tanezumab vs placebo comparison is the change from Baseline to Week 8 in the WOMAC Pain subscale (primary objective 1). - The primary endpoint for the tanezumab vs oxycodone CR comparison is the change from Baseline to Week 8 in the WOMAC Pain subscale (primary objective 2).
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Secondary Objective: • Evaluate the safety and tolerability up to Week 18 of tanezumab 10 mg and 5 mg administered IV every 8 weeks.
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Secondary ID(s)
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A4091030
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2009-013329-41-ES
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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