Clinical trial NCT01001923: Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Abdominal Pain Upper
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS)
timeFrame: baseline and 4 weeks after injection
Secondary outcomes:
measure: Mean change from baseline in pain intensity as assessed by PI-NRS
timeFrame: baseline and every other weeks up to 12 weeks after injection
measure: Percentage of pain-free days (score "0" pain on PI-NRS)
timeFrame: 12 weeks
measure: Percentage of days with rescue analgesia use
timeFrame: 12 weeks
measure: Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score
timeFrame: baseline and 4, 8, 12 weeks
measure: Patient Global Impression of Change [PGIC] score
timeFrame: 4, 8 and 12 weeks
measure: Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity
timeFrame: up to 12 weeks after injection
measure: Pharmacokinetic: REGN475/SAR164877 serum concentration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Sanofi-Aventis Investigational Site Number 840024
state: California
city: Bell Gardens
country: United States
facility: Sanofi-Aventis Investigational Site Number 840011
state: California
city: Monterey
country: United States
facility: Sanofi-Aventis Investigational Site Number 840003
state: California
city: San Diego
country: United States
facility: Sanofi-Aventis Investigational Site Number 840048
state: California
city: Stanford
country: United States
facility: Sanofi-Aventis Investigational Site Number 840034
state: California
city: Miami
country: United States
facility: Sanofi-Aventis Investigational Site Number 840031
state: Florida
city: St. Petersburg
country: United States
facility: Sanofi-Aventis Investigational Site Number 840029
state: Florida
city: Marietta
country: United States
facility: Sanofi-Aventis Investigational Site Number 840017
state: Georgia
city: Worcester
country: United States
facility: Sanofi-Aventis Investigational Site Number 840013
state: Massachusetts
city: Lebanon
country: United States
facility: Sanofi-Aventis Investigational Site Number 840030
state: New Hampshire
city: New York
country: United States
facility: Sanofi-Aventis Investigational Site Number 840023
state: New York
city: Winston Salem
country: United States
facility: Sanofi-Aventis Investigational Site Number 840052
state: North Carolina
city: Cleveland
country: United States
facility: Sanofi-Aventis Investigational Site Number 840005
state: Ohio
city: Dallas
country: United States
facility: Sanofi-Aventis Investigational Site Number 840043
state: Texas
city: Desoto
country: United States
facility: Sanofi-Aventis Investigational Site Number 840053
state: Texas
city: Southlake
country: United States
facility: Sanofi-Aventis Investigational Site Number 840050
state: Texas
city: East Sandy
country: United States
facility: Sanofi-Aventis Investigational Site Number 840040
state: Utah
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: