Long-Term Study Of The Safety Of Tanezumab In Arthritis Patients

NCT ID: NCT00960804

Last Updated: 2021-02-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-15

Study Completion Date

2010-11-11

Brief Summary

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Tanezumab, administered for up to 1 1/2 years, reduces the pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves

Detailed Description

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This study was terminated on 11 Nov 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 5 mg

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

IV, 5 mg dose, q 8 weeks, for up to 80 weeks

Tanezumab 10 mg

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

IV, 10 mg dose, q 8 weeks, for up to 80 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

IV, q 8 weeks, for up to 80 weeks

Interventions

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Tanezumab

IV, 5 mg dose, q 8 weeks, for up to 80 weeks

Intervention Type BIOLOGICAL

Tanezumab

IV, 10 mg dose, q 8 weeks, for up to 80 weeks

Intervention Type BIOLOGICAL

Placebo

IV, q 8 weeks, for up to 80 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must consent in writing to participate in the study.
* Patients must be willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
* Patients must have participated in the A4091026 study.

Exclusion Criteria

* Withdrawn from the A4091026 study for an adverse event or serious adverse event.
* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
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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Jem Research, LLC

Atlantis, Florida, United States

Site Status

Medical Specialists of the Palm Beaches

Atlantis, Florida, United States

Site Status

Clinical Physiology Associates, Clinical Study Center

Fort Myers, Florida, United States

Site Status

Harris Bonnette, MD

Fort Myers, Florida, United States

Site Status

Arthritis & Rheumatic Care Center

South Miami, Florida, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

Neuroscience Consultants, LLC

South Miami, Florida, United States

Site Status

Asheville Imaging

Asheville, North Carolina, United States

Site Status

Biltmore Medical Associates

Asheville, North Carolina, United States

Site Status

Clinical Study Center of Asheville, LLC

Asheville, North Carolina, United States

Site Status

Asheville Neurology

Asheville, North Carolina, United States

Site Status

Ohio Research Center

Toledo, Ohio, United States

Site Status

Blair Neurologic Associates

Altoona, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Coastal Carolina Research Center in Goose Creek

Goose Creek, South Carolina, United States

Site Status

Tidewater Neurology

Goose Creek, South Carolina, United States

Site Status

Neurodiagnostic Laboratories of San Antonio, Inc

San Antonio, Texas, United States

Site Status

Radiant Research, Inc.

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NERVE FUNCTION EXTENSION STUDY

Identifier Type: OTHER

Identifier Source: secondary_id

A4091040

Identifier Type: -

Identifier Source: org_study_id

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