Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
This study has been terminated.
(Business decision due to low subject recruitment and enrollment)
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01001923
First received: October 26, 2009
Last updated: October 23, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Pain Upper |
Drug: REGN475/SAR164877 Drug: Placebo (for REGN475/SAR164877) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS) [ Time Frame: baseline and 4 weeks after injection ] [ Designated as safety issue: No ]
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:
- Mean change from baseline in pain intensity as assessed by PI-NRS [ Time Frame: baseline and every other weeks up to 12 weeks after injection ] [ Designated as safety issue: No ]
- Percentage of pain-free days (score "0" pain on PI-NRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of days with rescue analgesia use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score [ Time Frame: baseline and 4, 8, 12 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change [PGIC] score [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity [ Time Frame: up to 12 weeks after injection ] [ Designated as safety issue: No ]
- Pharmacokinetic: REGN475/SAR164877 serum concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
|
Drug: REGN475/SAR164877
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
|
Placebo Comparator: Placebo
Placebo (for REGN475/SAR164877), single injection
|
Drug: Placebo (for REGN475/SAR164877)
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001923
Locations
| United States, California | |
| Sanofi-Aventis Investigational Site Number 840024 | |
| Arcadia, California, United States, 91007 | |
| Sanofi-Aventis Investigational Site Number 840011 | |
| Bell Gardens, California, United States, 90201 | |
| Sanofi-Aventis Investigational Site Number 840003 | |
| Monterey, California, United States, 93940 | |
| Sanofi-Aventis Investigational Site Number 840048 | |
| San Diego, California, United States, 92103 | |
| Sanofi-Aventis Investigational Site Number 840034 | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Sanofi-Aventis Investigational Site Number 840031 | |
| Miami, Florida, United States, 33144 | |
| Sanofi-Aventis Investigational Site Number 840029 | |
| St. Petersburg, Florida, United States, 33703 | |
| United States, Georgia | |
| Sanofi-Aventis Investigational Site Number 840017 | |
| Marietta, Georgia, United States, 30060 | |
| United States, Massachusetts | |
| Sanofi-Aventis Investigational Site Number 840013 | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New Hampshire | |
| Sanofi-Aventis Investigational Site Number 840030 | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Sanofi-Aventis Investigational Site Number 840023 | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Sanofi-Aventis Investigational Site Number 840052 | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Sanofi-Aventis Investigational Site Number 840005 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Sanofi-Aventis Investigational Site Number 840043 | |
| Dallas, Texas, United States, 75204 | |
| Sanofi-Aventis Investigational Site Number 840053 | |
| Desoto, Texas, United States, 75115 | |
| Sanofi-Aventis Investigational Site Number 840050 | |
| Southlake, Texas, United States, 76092 | |
| United States, Utah | |
| Sanofi-Aventis Investigational Site Number 840040 | |
| East Sandy, Utah, United States, 84094 | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01001923 History of Changes |
| Other Study ID Numbers: | ACT11286 |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Abdominal Pain Pancreatitis Pancreatitis, Chronic Pain |
Signs and Symptoms Signs and Symptoms, Digestive Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013