Tanezumab in Osteoarthritis of the Hip or Knee (2)
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ClinicalTrials.gov Identifier: NCT00863304 |
Recruitment Status :
Completed
First Posted : March 17, 2009
Results First Posted : May 17, 2021
Last Update Posted : May 17, 2021
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Osteoarthritis |
Interventions |
Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: naproxen Other: placebo |
Enrollment | 849 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | Tanezumab 5 mg + Placebo | Tanezumab 10 mg + Placebo | Naproxen + Placebo |
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Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12. | Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. | Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. | Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8. |
Period Title: Overall Study | ||||
Started | 212 | 212 | 213 | 212 |
Treated | 209 | 211 | 209 | 211 |
Completed | 18 | 27 | 26 | 21 |
Not Completed | 194 | 185 | 187 | 191 |
Reason Not Completed | ||||
Adverse Event | 10 | 4 | 14 | 16 |
Lost to Follow-up | 1 | 5 | 4 | 2 |
Lack of Efficacy | 57 | 26 | 30 | 28 |
Withdrawal by Subject | 19 | 14 | 20 | 18 |
Other | 1 | 0 | 0 | 1 |
Protocol Violation | 2 | 6 | 2 | 0 |
Randomized, but not Treated | 3 | 1 | 4 | 1 |
Entered extension study | 101 | 129 | 113 | 125 |
Baseline Characteristics
Arm/Group Title | Placebo | Tanezumab 5 mg + Placebo | Tanezumab 10 mg + Placebo | Naproxen + Placebo | Total | |
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Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12. | Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. | Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12. | Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8. | Total of all reporting groups | |
Overall Number of Baseline Participants | 209 | 211 | 209 | 211 | 840 | |
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Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of randomized IV study medication (either tanezumab or placebo IV).
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 209 participants | 211 participants | 209 participants | 211 participants | 840 participants | |
18 to 44 years |
6 2.9%
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13 6.2%
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14 6.7%
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14 6.6%
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47 5.6%
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45 to 64 years |
133 63.6%
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133 63.0%
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134 64.1%
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126 59.7%
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526 62.6%
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Greater than or equal to (>=) 65 years |
70 33.5%
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65 30.8%
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61 29.2%
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71 33.6%
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267 31.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 209 participants | 211 participants | 209 participants | 211 participants | 840 participants | |
Female |
136 65.1%
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134 63.5%
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128 61.2%
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136 64.5%
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534 63.6%
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Male |
73 34.9%
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77 36.5%
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81 38.8%
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75 35.5%
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306 36.4%
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