Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury
ClinicalTrials.gov ID
NCT01053702
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Phase 2
Enrollment
0Actual
Last Update Posted
Apr 19, 2011Estimated
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.
Thermal Injury Pain
R475
Placebo
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
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.