Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
TerminatedPhase 2NCT01001923
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis
- Conditions
- Abdominal Pain Upper
- Interventions
- Drug: REGN475/SAR164877
- Drug: Placebo (for REGN475/SAR164877)
- Sponsor
- Regeneron Pharmaceuticals
- Start date
- 2009-12
- Primary completion
- 2011-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 17
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01001923