Clinical Trial: Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: Tanezumab is effective in reducing the pain associated with chronic pancreatitis.

Detailed Summary: 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.
Sponsor: Pfizer

Current Primary Outcome: Change from baseline in average chronic pancreatitis pain intensity score. [ Time Frame: Baseline, 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in average chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in worst chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in Brief Pain Inventory (BPI) -short form [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in Patient's Global Assessment of Chronic Pancreatitis [ Time Frame: Baseline, 16 weeks ]
  • Tanezumab levels in the plasma [ Time Frame: Baseline, 16 weeks ]
  • Anti-tanezumab antibodies in the serum [ Time Frame: Baseline, 16 weeks ]
  • Serum Nerve Growth Factor (NGF) levels [ Time Frame: Baseline, 16 weeks ]
  • Safety laboratory [ Time Frame: Baseline, 16 weeks ]
  • Adverse Events [ Time Frame: Baseline, 16 weeks ]
  • ECG [ Time Frame: Baseline, 16 weeks ]


Original Secondary Outcome:

  • Change from baseline in average chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in worst chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in Brief Pain Inventory (BPI) -short form [ Time Frame: Baseline, 16 weeks ]
  • Change from baseline in Patient's Global Assessment of Chronic Pancreatitis [ Time Frame: Baseline, 16 weeks ]
  • Tanezumab levels in the plasma [ Time Frame: Baseline, 16 weeks ]
  • Anti-tanezumab antibodies in the serum [ Time Frame: Baseline, 16 weeks ]
  • Serum Nerve Growth Factor (NGF) levels [ Time Frame: Baseline, 16 weeks ]


Information By: Pfizer

Dates:
Date Received: May 24, 2010
Date Started: October 2010
Date Completion:
Last Updated: August 23, 2012
Last Verified: August 2012