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Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

NCT01089725 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2021-05-05

Study results available
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Summary

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

Conditions

Interventions

BIOLOGICAL

Placebo IV

1 ml of placebo administered SC and IV once every 8 weeks.

BIOLOGICAL

Placebo SC

1 ml of placebo administered SC and IV once every 8 weeks.

BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

BIOLOGICAL

Placebo IV

1 ml placebo administered IV every 8 weeks

BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

BIOLOGICAL

Placebo IV

1ml placebo administered IV every 8 weeks

BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

BIOLOGICAL

Placebo IV

1ml placebo administered IV every 8 weeks

BIOLOGICAL

Tanezumab IV

1 ml tanezumab injection IV administered every 8 weeks

BIOLOGICAL

Placebo SC

1ml placebo administered SC every 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-30
Primary Completion
2010-11-08
Completion
2011-02-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089725 on ClinicalTrials.gov