NCT01146561

Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
BIOLOGICAL	Tanezumab	single administration of tanezumab 20 mg sub-cutaneously
OTHER	Placebo	single administration of placebo to match tanezumab, sub-cutaneously

Timeline

• Start date: 2010-10-13
• Primary completion: 2011-03-22
• Completion: 2011-03-22
• First posted: 2010-06-17
• Last updated: 2021-03-23
• Results posted: 2021-03-23

Locations

9 sites across 1 country: United States