Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

Treatments: Biological: Tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127893

A4091032

SAFETY EXTENSION OF 1027 (Other Identifier)

Details and patient eligibility

About

An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks

Full description

This study was terminated on 29 September 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: 1 patient

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have participated in specific Phase 3 parent study

Exclusion criteria

• Failed screening for parent study, pregnant women, lactating mothers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 3 patient groups

Tanezumab 10 mg

Experimental group

Treatment:

Biological: Tanezumab

Biological: Tanezumab

Biological: Tanezumab

Tanezumab 5 mg

Experimental group

Treatment:

Biological: Tanezumab

Biological: Tanezumab

Biological: Tanezumab

Tanezumab 2.5 mg

Experimental group

Treatment:

Biological: Tanezumab

Biological: Tanezumab

Biological: Tanezumab