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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:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01001923
First received: October 26, 2009
Last updated: May 20, 2013
Last verified: May 2013
  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 Regeneron Pharmaceuticals:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01001923     History of Changes
Other Study ID Numbers: ACT11286
Study First Received: October 26, 2009
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014