Status:
TERMINATED
Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Abdominal Pain Upper
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 o...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01001923
Start Date
December 1 2009
End Date
January 1 2011
Last Update
May 27 2013
Active Locations (17)
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1
Sanofi-Aventis Investigational Site Number 840024
Arcadia, California, United States, 91007
2
Sanofi-Aventis Investigational Site Number 840011
Bell Gardens, California, United States, 90201
3
Sanofi-Aventis Investigational Site Number 840003
Monterey, California, United States, 93940
4
Sanofi-Aventis Investigational Site Number 840048
San Diego, California, United States, 92103