NCT00994890

A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND,LONG TERM STUDY OF THE SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 679 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Detailed description

Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	Tanezumab 2.5 mg	Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
DRUG	Tanezumab 5 mg	Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
DRUG	Tanezumab 10 mg	Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Timeline

• Start date: 2009-11-17
• Primary completion: 2010-12-07
• Completion: 2011-03-01
• First posted: 2009-10-14
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

100 sites across 1 country: United States