Abdominal Pain Upper Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment