Tanezumab in Osteoarthritis of the Hip or Knee (2)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Other: placebo; Biological: tanezumab 5 mg; Biological: tanezumab 10 mg; Drug: naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863304

A4091018

Details and patient eligibility

About

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

Enrollment: 849 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion criteria

• pregnancy or intent to become pregnant
• BMI greater than 39
• other severe pain, significant cardiac, neurological or psychiatric disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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849 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Biological: tanezumab 10 mg

2

Experimental group

Treatment:

Biological: tanezumab 5 mg

3

Active Comparator group

Treatment:

Drug: naproxen

4

Placebo Comparator group

Treatment:

Other: placebo