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

NCT01001923 | Terminated Phase 2 DMC

• 1 other identifier: ACT11286
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 17

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.

Conditions

Abdominal Pain Upper

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS)

  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 Outcomes (7)

• Mean change from baseline in pain intensity as assessed by PI-NRS

  baseline and every other weeks 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

• 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

Study Arms (2)

REGN475/SAR164877

EXPERIMENTAL

REGN475/SAR164877, single injection, dose depending on the participant's body weight

Drug: REGN475/SAR164877

Placebo

PLACEBO COMPARATOR

Placebo (for REGN475/SAR164877), single injection

Drug: Placebo (for REGN475/SAR164877)

Interventions

REGN475/SAR164877 DRUG

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

REGN475/SAR164877

Placebo (for REGN475/SAR164877) DRUG

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe abdominal pain due to chronic pancreatitis of at least 6 months duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (17)

Sanofi-Aventis Investigational Site Number 840024

Arcadia, California, 91007, United States

Location

Sanofi-Aventis Investigational Site Number 840011

Bell Gardens, California, 90201, United States

Location

Sanofi-Aventis Investigational Site Number 840003

Monterey, California, 93940, United States

Location

Sanofi-Aventis Investigational Site Number 840048

San Diego, California, 92103, United States

Location

Sanofi-Aventis Investigational Site Number 840034

Stanford, California, 94305, United States

Location

Sanofi-Aventis Investigational Site Number 840031

Miami, Florida, 33144, United States

Location

Sanofi-Aventis Investigational Site Number 840029

St. Petersburg, Florida, 33703, United States

Location

Sanofi-Aventis Investigational Site Number 840017

Marietta, Georgia, 30060, United States

Location

Sanofi-Aventis Investigational Site Number 840013

Worcester, Massachusetts, 01655, United States

Location

Sanofi-Aventis Investigational Site Number 840030

Lebanon, New Hampshire, 03756, United States

Location

Sanofi-Aventis Investigational Site Number 840023

New York, New York, 10016, United States

Location

Sanofi-Aventis Investigational Site Number 840052

Winston-Salem, North Carolina, 27103, United States

Location

Sanofi-Aventis Investigational Site Number 840005

Cleveland, Ohio, 44195, United States

Location

Sanofi-Aventis Investigational Site Number 840043

Dallas, Texas, 75204, United States

Location

Sanofi-Aventis Investigational Site Number 840053

DeSoto, Texas, 75115, United States

Location

Sanofi-Aventis Investigational Site Number 840050

Southlake, Texas, 76092, United States

Location

Sanofi-Aventis Investigational Site Number 840040

East Sandy, Utah, 84094, United States

Location

MeSH Terms

Interventions

fasinumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (17)