Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001923
Recruitment Status : Terminated (Business decision due to low subject recruitment and enrollment)
First Posted : October 27, 2009
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Upper Drug: REGN475/SAR164877 Drug: Placebo (for REGN475/SAR164877) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]
  2. Percentage of pain-free days (score "0" pain on PI-NRS) [ Time Frame: 12 weeks ]
  3. Percentage of days with rescue analgesia use [ Time Frame: 12 weeks ]
  4. Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score [ Time Frame: baseline and 4, 8, 12 weeks ]
  5. Patient Global Impression of Change [PGIC] score [ Time Frame: 4, 8 and 12 weeks ]
  6. Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity [ Time Frame: up to 12 weeks after injection ]
  7. Pharmacokinetic: REGN475/SAR164877 serum concentration [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001923

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
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01001923     History of Changes
Other Study ID Numbers: ACT11286
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Abdominal Pain
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive