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

Regeneron Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Thermal Injury Pain

Treatments: Drug: R475; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01053702

R475-PN-0909

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Dose 1

Experimental group

Description:

R475

Treatment:

Drug: R475

Dose 2

Experimental group

Description:

R475

Treatment:

Drug: R475

Dose 3

Placebo Comparator group

Description:

Placebo to match R475 dose

Treatment:

Drug: Placebo