NCT01001923

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

Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Abdominal Pain Upper

Interventions

Type	Name	Description
DRUG	REGN475/SAR164877	Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes
DRUG	Placebo (for REGN475/SAR164877)	Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-10-27
• Last updated: 2013-05-27

Locations

17 sites across 1 country: United States