Tanezumab In Osteoarthritis Of The Hip Or Knee

NCT ID: NCT00985621

Last Updated: 2021-05-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-30

Study Completion Date

2011-02-04

Brief Summary

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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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

tanezumab 10 mg

Intervention Type BIOLOGICAL

tanezumab 10 mg one dose at weeks 0 and 8

2

Group Type EXPERIMENTAL

tanezumab 5 mg

Intervention Type BIOLOGICAL

tanezumab 5 mg one dose at weeks 0 and 8

3

Group Type ACTIVE_COMPARATOR

oxycodone

Intervention Type DRUG

oxycodone CR, 10-40 mg q12h

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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tanezumab 10 mg

tanezumab 10 mg one dose at weeks 0 and 8

Intervention Type BIOLOGICAL

tanezumab 5 mg

tanezumab 5 mg one dose at weeks 0 and 8

Intervention Type BIOLOGICAL

oxycodone

oxycodone CR, 10-40 mg q12h

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Achieve Clinical Research

Birmingham, Alabama, United States

Site Status

Alabama Orthopaedic Clinics, PC

Mobile, Alabama, United States

Site Status

Horizon Research Group, Inc.

Mobile, Alabama, United States

Site Status

Arizona Research Center, Inc.

Phoenix, Arizona, United States

Site Status

Osteoporosis Medical Center

Beverly Hills, California, United States

Site Status

Med Frontier Clinical Research

Buena Park, California, United States

Site Status

Providence Clinical Research

Burbank, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Medvin Clinical Research

Van Nuys, California, United States

Site Status

Advanced Radiology

Stamford, Connecticut, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Homestead Clinical Research Group, P.A.

Cutler Bay, Florida, United States

Site Status

Riverside Clinical Research

Edgewater, Florida, United States

Site Status

Florida Clinical Research Center, LLC

Fruitland Park, Florida, United States

Site Status

Adult Medicine Specialists

Longwood, Florida, United States

Site Status

Genesis Research International

Longwood, Florida, United States

Site Status

Community Research Foundation, Inc.

Miami, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Advent Clinical Research Centers, Inc.

Pinellas Park, Florida, United States

Site Status

Sarasota Center For Clinical Research

Sarasota, Florida, United States

Site Status

Dale G. Bramlet, MD

St. Petersburg, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Laureate Clinical Research Group

Atlanta, Georgia, United States

Site Status

Drug Studies America Inc.

Marietta, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Goergia Internal Medicine

Woodstock, Georgia, United States

Site Status

Americana Orthopedics

Boise, Idaho, United States

Site Status

Sonora Clinical Research, LLC.

Boise, Idaho, United States

Site Status

Northwest Indiana Center for Clinical Research

Valparaiso, Indiana, United States

Site Status

Commonwealth Biomedical Research

Madisonville, Kentucky, United States

Site Status

Mid-Atlantic Medical Research

Hollywood, Maryland, United States

Site Status

Miray Medical Center

Brockton, Massachusetts, United States

Site Status

MedVadis Research Corporation

Watertown, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Great Lakes Research Group, Incorporated

Bay City, Michigan, United States

Site Status

The Center for Clinical Trials

Biloxi, Mississippi, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Diagnostic Center of Medicine

Henderson, Nevada, United States

Site Status

Office of Matthew Barton, MD

Las Vegas, Nevada, United States

Site Status

Comprehensive Clinical Research

Berlin, New Jersey, United States

Site Status

Office of Andrew J. Porges, MD PC

Roslyn, New York, United States

Site Status

MediSpect, LLC

Boone, North Carolina, United States

Site Status

Crescent Medical Research

Salisbury, North Carolina, United States

Site Status

Hilltop Medical Research Center

Cincinnati, Ohio, United States

Site Status

Columbus Clinical Research

Columbus, Ohio, United States

Site Status

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

Site Status

Piedmont Arthritis Clinic, PA

Greenville, South Carolina, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

TriCities Medical Research

Bristol, Tennessee, United States

Site Status

Appalachian Medical Research Inc.

Johnson City, Tennessee, United States

Site Status

ClinRx Research, LLC

Carrollton, Texas, United States

Site Status

Tekton Research, Inc

Georgetown, Texas, United States

Site Status

One Step Diagnostic (X-Ray Facility)

Houston, Texas, United States

Site Status

Pioneer Research Solutions

Houston, Texas, United States

Site Status

Leander Healthcare Center

Leander, Texas, United States

Site Status

ClinRx Research

Richardson, Texas, United States

Site Status

Oakwell Clinical research, LLC

San Antonio, Texas, United States

Site Status

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

LKH/Universitatsklinikum Graz

Graz, , Austria

Site Status

Nuhr Zentrum

Senftenberg, , Austria

Site Status

ClinPharm International GmbH

Vienna, , Austria

Site Status

Synexus ClinPharm GmbH

Vienna, , Austria

Site Status

Rheuma Zentrum Favoriten

Vienna, , Austria

Site Status

CCBR A/S

Aalborg, , Denmark

Site Status

CCBR A/S

Ballerup Municipality, , Denmark

Site Status

Frederiksberg Hospital Parker Institute

Frederiksberg, , Denmark

Site Status

CCBR A/S

Vejle, , Denmark

Site Status

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Klinische Forschung Berlin-Buch GmbH

Berlin, , Germany

Site Status

Viereck-Apotheke

Berlin, , Germany

Site Status

Charité Campus Virchow-Klinikum Apotheke

Berlin, , Germany

Site Status

ClinPharm International GmbH

Bochum, , Germany

Site Status

Herz Apotheke

Bochum, , Germany

Site Status

Synexus ClinPharm GmbH

Bochum, , Germany

Site Status

Synexus ClinPharm GmbH / Frankfurt/M

Frankfurt am Main, , Germany

Site Status

Schiller-Apotheke

Göppingen, , Germany

Site Status

Schmerz und Palliativ-Zentrum Goppingen

Göppingen, , Germany

Site Status

Falken Apotheke Hoheluft

Hamburg, , Germany

Site Status

Klinische Forschung Hamburg GmbH

Hamburg, , Germany

Site Status

Klinische Forschung Hannover-Mitte GmbH

Hanover, , Germany

Site Status

Löwen Apotheke

Hanover, , Germany

Site Status

Synexus ClinPharm GmbH

Leipzig, , Germany

Site Status

Arkana Apotheke OHG

Leipzig, , Germany

Site Status

Synexus ClinPharm GmbH Pruefzentrum Magdeburg

Magdeburg, , Germany

Site Status

Apotheke im MSZ

Magdeburg, , Germany

Site Status

Schwanen Apotheke am Markt

Offenbach, , Germany

Site Status

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Site Status

Sonnenapotheke

Schwerin, , Germany

Site Status

Nzoz Centrum Medyczne

Bialystok, , Poland

Site Status

Szpital Specjalistyczny im. J. Dietla

Krakow, , Poland

Site Status

NZOZ REUMED Sp.zo.o.

Lublin, , Poland

Site Status

Medyczne Centrum Hetmanska

Poznan, , Poland

Site Status

NZOZ "Nasz Lekarz"

Torun, , Poland

Site Status

Centrum Medyczne OSTEOMED NZOZ

Warsaw, , Poland

Site Status

Hospital Nuestra Senora de la Esperanza

Santiago de Compostela, A Coruña, Spain

Site Status

Complejo Hospitalario Universitario de A Coruna

A Coruña, , Spain

Site Status

Hospital Regional Universitario Carlos Haya (Hospital Civil)

Málaga, , Spain

Site Status

Hospital Regional Universitario Carlos Haya (Hospital Civil)

Málaga, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Me3plus AB

Gothenburg, , Sweden

Site Status

Me3plus AB

Gothenburg, , Sweden

Site Status

Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Center for Clinical Studies

Malmo, , Sweden

Site Status

Bragee Medect AB

Stockholm, , Sweden

Site Status

Countries

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United States Austria Denmark Germany Poland Spain Sweden

References

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Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.

Reference Type DERIVED
PMID: 37460782 (View on PubMed)

Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.

Reference Type DERIVED
PMID: 30936738 (View on PubMed)

Spierings ELH, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013 Sep;154(9):1603-1612. doi: 10.1016/j.pain.2013.04.035. Epub 2013 Apr 22.

Reference Type DERIVED
PMID: 23707270 (View on PubMed)

Related Links

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Other Identifiers

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2009-013329-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OA OXY STUDY

Identifier Type: OTHER

Identifier Source: secondary_id

A4091030

Identifier Type: -

Identifier Source: org_study_id

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