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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Thermal Injury Pain

In brief

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.

Key facts

Study ID

NCT01053702

Run by

Regeneron Pharmaceuticals

People needed

0

Last updated by the study team

2011-04-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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