Extension Study Of Tanezumab In Osteoarthritis

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

Treatments: Biological: tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809783

P3 LONG TERM SAFETY EXTENSION (Other Identifier)

A4091016

Details and patient eligibility

About

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Full description

This study was terminated on 27 October 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: 2,147 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion criteria

• Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,147 participants in 3 patient groups

Tanezumab 10 mg

Experimental group

Description:

Tanezumab 10 mg

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 5 mg

Experimental group

Description:

Tanezumab 5 mg

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Tanezumab 2.5 mg

Experimental group

Description:

Tanezumab 2.5 mg

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab