Abdominal Pain Upper Clinical Trial
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
| Verified date | May 2013 |
| Source | Regeneron Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | 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 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 840040 | East Sandy | Utah |
| United States | Sanofi-Aventis Investigational Site Number 840030 | Lebanon | New Hampshire |
| United States | Sanofi-Aventis Investigational Site Number 840017 | Marietta | Georgia |
| United States | Sanofi-Aventis Investigational Site Number 840031 | Miami | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840003 | Monterey | California |
| United States | Sanofi-Aventis Investigational Site Number 840023 | New York | New York |
| United States | Sanofi-Aventis Investigational Site Number 840048 | San Diego | California |
| United States | Sanofi-Aventis Investigational Site Number 840050 | Southlake | Texas |
| United States | Sanofi-Aventis Investigational Site Number 840029 | St. Petersburg | Florida |
| United States | Sanofi-Aventis Investigational Site Number 840034 | Stanford | California |
| United States | Sanofi-Aventis Investigational Site Number 840052 | Winston Salem | North Carolina |
| United States | Sanofi-Aventis Investigational Site Number 840013 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Regeneron Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS) | The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit. The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4. |
baseline and 4 weeks after injection | No |
| Secondary | Mean change from baseline in pain intensity as assessed by PI-NRS | baseline and every other weeks up to 12 weeks after injection | No | |
| Secondary | Percentage of pain-free days (score "0" pain on PI-NRS) | 12 weeks | No | |
| Secondary | Percentage of days with rescue analgesia use | 12 weeks | No | |
| Secondary | Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score | baseline and 4, 8, 12 weeks | No | |
| Secondary | Patient Global Impression of Change [PGIC] score | 4, 8 and 12 weeks | No | |
| Secondary | Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity | up to 12 weeks after injection | No | |
| Secondary | Pharmacokinetic: REGN475/SAR164877 serum concentration | 12 weeks | No |