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

Thermal Injury Pain Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01053702
• Other study ID #: R475-PN-0909
• Status: Withdrawn
• Phase: Phase 2
• First received: January 19, 2010
• Last updated: April 17, 2011

Study information

• Verified date: April 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thermal Injury Pain

Intervention

Drug:
• R475
IV
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in procedural pain intensity			No
Secondary	Cumulative analgesic usage			No
Secondary	Weekly Patient-rated Global Impression of Change			No
Secondary	Additional quality of life assessments			No