Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Fasinumab

Criteria

Inclusion criteria:

• Moderate to severe abdominal pain due to chronic pancreatitis of at least 6 months duration.

Exclusion criteria:

• Mild pain on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;

• Narcotic addiction;

• Recent pancreatic surgical or endoscopic intervention for chronic pancreatitis pain;

• Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.