Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury
Phase 2
Withdrawn
- Conditions
- Thermal Injury Pain
- Interventions
- Drug: R475Drug: Placebo
- Registration Number
- NCT01053702
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
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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.
- Women who are pregnant or nursing
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 R475 R475 Dose 2 R475 R475 Dose 3 Placebo Placebo to match R475 dose
- Primary Outcome Measures
Name Time Method Change in procedural pain intensity
- Secondary Outcome Measures
Name Time Method Cumulative analgesic usage Weekly Patient-rated Global Impression of Change Additional quality of life assessments