- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01001923
Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Arcadia, California, United States, 91007
- Sanofi-Aventis Investigational Site Number 840024
-
Bell Gardens, California, United States, 90201
- Sanofi-Aventis Investigational Site Number 840011
-
Monterey, California, United States, 93940
- Sanofi-Aventis Investigational Site Number 840003
-
San Diego, California, United States, 92103
- Sanofi-Aventis Investigational Site Number 840048
-
Stanford, California, United States, 94305
- Sanofi-Aventis Investigational Site Number 840034
-
-
Florida
-
Miami, Florida, United States, 33144
- Sanofi-Aventis Investigational Site Number 840031
-
St. Petersburg, Florida, United States, 33703
- Sanofi-Aventis Investigational Site Number 840029
-
-
Georgia
-
Marietta, Georgia, United States, 30060
- Sanofi-Aventis Investigational Site Number 840017
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- Sanofi-Aventis Investigational Site Number 840013
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Sanofi-Aventis Investigational Site Number 840030
-
-
New York
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New York, New York, United States, 10016
- Sanofi-Aventis Investigational Site Number 840023
-
-
North Carolina
-
Winston Salem, North Carolina, United States, 27103
- Sanofi-Aventis Investigational Site Number 840052
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Sanofi-Aventis Investigational Site Number 840005
-
-
Texas
-
Dallas, Texas, United States, 75204
- Sanofi-Aventis Investigational Site Number 840043
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Desoto, Texas, United States, 75115
- Sanofi-Aventis Investigational Site Number 840053
-
Southlake, Texas, United States, 76092
- Sanofi-Aventis Investigational Site Number 840050
-
-
Utah
-
East Sandy, Utah, United States, 84094
- Sanofi-Aventis Investigational Site Number 840040
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: REGN475/SAR164877
REGN475/SAR164877, single injection, dose depending on the participant's body weight
|
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
Placebo Comparator: Placebo
Placebo (for REGN475/SAR164877), single injection
|
Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline and every other weeks up to 12 weeks after injection
|
Percentage of pain-free days (score "0" pain on PI-NRS)
Time Frame: 12 weeks
|
12 weeks
|
Percentage of days with rescue analgesia use
Time Frame: 12 weeks
|
12 weeks
|
Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
Time Frame: baseline and 4, 8, 12 weeks
|
baseline and 4, 8, 12 weeks
|
Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
Time Frame: up to 12 weeks after injection
|
up to 12 weeks after injection
|
Pharmacokinetic: REGN475/SAR164877 serum concentration
Time Frame: 12 weeks
|
12 weeks
|
Patient Global Impression of Change [PGIC] score
Time Frame: 4, 8 and 12 weeks
|
4, 8 and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT11286
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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