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

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ClinicalTrials.gov Identifier: NCT01053702
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : January 21, 2010
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
Sanofi
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
R475
Drug: R475
IV
Experimental: Dose 2
R475
Drug: R475
IV
Placebo Comparator: Dose 3
Placebo to match R475 dose
Drug: Placebo
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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01053702


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

Responsible Party: Medical Director, Regeneron Pharmaceuticals
ClinicalTrials.gov 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:
Burns
Wounds and Injuries