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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Abdominal Pain Upper

In brief

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.

Key facts

Study ID

NCT01001923

Run by

Regeneron Pharmaceuticals

People needed

15

Starts

2009-12-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Investigational Site Number 840024 — Arcadia, California, United States
• Sanofi-Aventis Investigational Site Number 840011 — Bell Gardens, California, United States
• Sanofi-Aventis Investigational Site Number 840003 — Monterey, California, United States
• Sanofi-Aventis Investigational Site Number 840048 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840034 — Stanford, California, United States
• Sanofi-Aventis Investigational Site Number 840031 — Miami, Florida, United States
• Sanofi-Aventis Investigational Site Number 840029 — St. Petersburg, Florida, United States
• Sanofi-Aventis Investigational Site Number 840017 — Marietta, Georgia, United States
• Sanofi-Aventis Investigational Site Number 840013 — Worcester, Massachusetts, United States
• Sanofi-Aventis Investigational Site Number 840030 — Lebanon, New Hampshire, United States
• Sanofi-Aventis Investigational Site Number 840023 — New York, New York, United States
• Sanofi-Aventis Investigational Site Number 840052 — Winston-Salem, North Carolina, United States
• Sanofi-Aventis Investigational Site Number 840005 — Cleveland, Ohio, United States
• Sanofi-Aventis Investigational Site Number 840043 — Dallas, Texas, United States
• Sanofi-Aventis Investigational Site Number 840053 — DeSoto, Texas, United States
• Sanofi-Aventis Investigational Site Number 840050 — Southlake, Texas, United States
• Sanofi-Aventis Investigational Site Number 840040 — East Sandy, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.