Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT01146561
Status:
TERMINATED
Last Update Posted:
2021-03-23
First Post:
2010-05-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
Status:
TERMINATED
Status Verified Date:
2021-01
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:
Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
Detailed Description:
On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.
Study Oversight
Has Oversight DMC:
False
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?: