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

NCT ID: NCT01127893

Last Updated: 2021-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-15

Study Completion Date

2010-09-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tanezumab 10 mg

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Tanezumab 5 mg

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Tanezumab 2.5 mg

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Interventions

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Tanezumab

Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Intervention Type BIOLOGICAL

Tanezumab

Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Intervention Type BIOLOGICAL

Tanezumab

Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Must have participated in specific Phase 3 parent study

Exclusion Criteria

* Failed screening for parent study, pregnant women, lactating mothers
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Triwest Research Associates

La Mesa, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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SAFETY EXTENSION OF 1027

Identifier Type: OTHER

Identifier Source: secondary_id

A4091032

Identifier Type: -

Identifier Source: org_study_id

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