Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT01127893
Status:
TERMINATED
Last Update Posted:
2021-03-10
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SAFETY EXTENSION OF 1027 | OTHER | Alias Study Number | View |