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Clinical Trial Summary

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with chronic pancreatitis.

Secondary objectives were:

- to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic pancreatitis pain;

- to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of REGN475/SAR164877 in this population;

- to measure the change in the total daily dose of rescue medications required.


Clinical Trial Description

The duration of the study period for each participant was up to 14 weeks, including a screening period up to 2 weeks, and 12-week follow-up after the injection. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01001923
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Terminated
Phase Phase 2
Start date December 2009
Completion date January 2011