Tanezumab In Osteoarthritis Of The Hip Or Knee

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985621

A4091030

2009-013329-41 (EudraCT Number)

OA OXY STUDY (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Full description

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Enrollment: 614 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• osteoarthritis of the knee or hip 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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614 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: oxycodone

4

Placebo Comparator group

Treatment:

Other: placebo