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Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

Primary Purpose

Thermal Injury Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R475
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thermal Injury Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury
  2. Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days

Exclusion Criteria:

  1. Patients with burns caused by chemical exposure or electricity
  2. Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection
  3. Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries
  4. Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments.
  5. Women who are pregnant or nursing

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1

Dose 2

Dose 3

Arm Description

R475

R475

Placebo to match R475 dose

Outcomes

Primary Outcome Measures

Change in procedural pain intensity

Secondary Outcome Measures

Cumulative analgesic usage
Weekly Patient-rated Global Impression of Change
Additional quality of life assessments

Full Information

First Posted
January 19, 2010
Last Updated
April 17, 2011
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01053702
Brief Title
Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermal Injury Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
R475
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
R475
Arm Title
Dose 3
Arm Type
Placebo Comparator
Arm Description
Placebo to match R475 dose
Intervention Type
Drug
Intervention Name(s)
R475
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in procedural pain intensity
Secondary Outcome Measure Information:
Title
Cumulative analgesic usage
Title
Weekly Patient-rated Global Impression of Change
Title
Additional quality of life assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days Exclusion Criteria: Patients with burns caused by chemical exposure or electricity Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments. Women who are pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tiseo, PhD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Tampa
State/Province
Florida
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

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