Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
NCT ID: NCT01001923
Last Updated: 2013-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2009-12-31
2011-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
REGN475/SAR164877
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
Placebo
Placebo (for REGN475/SAR164877), single injection
Placebo (for REGN475/SAR164877)
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
Interventions
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REGN475/SAR164877
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
Placebo (for REGN475/SAR164877)
Pharmaceutical form: solution
Route of administration: intravenous infusion over 30 minutes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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Other Identifiers
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ACT11286
Identifier Type: -
Identifier Source: org_study_id
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