Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
- Conditions
- Abdominal Pain Upper
- Interventions
- Drug: Placebo (for REGN475/SAR164877)Drug: REGN475/SAR164877
- Registration Number
- NCT01001923
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (for REGN475/SAR164877) Placebo (for REGN475/SAR164877), single injection REGN475/SAR164877 REGN475/SAR164877 REGN475/SAR164877, single injection, dose depending on the participant's body weight
- Primary Outcome Measures
Name Time Method Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS) baseline and 4 weeks after injection 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.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic: REGN475/SAR164877 serum concentration 12 weeks Mean change from baseline in pain intensity as assessed by PI-NRS baseline and every other weeks up to 12 weeks after injection Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score baseline and 4, 8, 12 weeks Patient Global Impression of Change [PGIC] score 4, 8 and 12 weeks Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity up to 12 weeks after injection Percentage of pain-free days (score "0" pain on PI-NRS) 12 weeks Percentage of days with rescue analgesia use 12 weeks
Trial Locations
- Locations (17)
Sanofi-Aventis Investigational Site Number 840043
🇺🇸Dallas, Texas, United States
Sanofi-Aventis Investigational Site Number 840003
🇺🇸Monterey, California, United States
Sanofi-Aventis Investigational Site Number 840052
🇺🇸Winston Salem, North Carolina, United States
Sanofi-Aventis Investigational Site Number 840048
🇺🇸San Diego, California, 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 840031
🇺🇸Miami, Florida, United States
Sanofi-Aventis Investigational Site Number 840017
🇺🇸Marietta, Georgia, United States
Sanofi-Aventis Investigational Site Number 840005
🇺🇸Cleveland, Ohio, United States
Sanofi-Aventis Investigational Site Number 840029
🇺🇸St. Petersburg, Florida, United States
Sanofi-Aventis Investigational Site Number 840013
🇺🇸Worcester, Massachusetts, 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 840034
🇺🇸Stanford, California, United States
Sanofi-Aventis Investigational Site Number 840023
🇺🇸New York, New York, United States
Sanofi-Aventis Investigational Site Number 840050
🇺🇸Southlake, Texas, United States
Sanofi-Aventis Investigational Site Number 840030
🇺🇸Lebanon, New Hampshire, United States