Thermal Injury Pain
Conditions
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.
Interventions
DRUGR475
IV
DRUGPlacebo
Placebo
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in procedural pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative analgesic usage | — |
| Weekly Patient-rated Global Impression of Change | — |
| Additional quality of life assessments | — |
Countries
United States
Outcome results
None listed