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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053702
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : January 21, 2010
Last Update Posted : April 19, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Thermal Injury Pain Drug: R475 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Arm Intervention/treatment
Experimental: Dose 1
Drug: R475

Experimental: Dose 2
Drug: R475

Placebo Comparator: Dose 3
Placebo to match R475 dose
Drug: Placebo

Primary Outcome Measures :
  1. Change in procedural pain intensity

Secondary Outcome Measures :
  1. Cumulative analgesic usage
  2. Weekly Patient-rated Global Impression of Change
  3. Additional quality of life assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053702

United States, Florida
Tampa, Florida, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Paul Tiseo, PhD Regeneron Pharmaceuticals

Responsible Party: Medical Director, Regeneron Pharmaceuticals Identifier: NCT01053702     History of Changes
Other Study ID Numbers: R475-PN-0909
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Wounds and Injuries