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

This study has been withdrawn prior to enrollment.
(Sponsor decision)
Sponsor:
Collaborator:
Sanofi
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01053702
First received: January 19, 2010
Last updated: April 17, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Thermal Injury Pain
 Drug: R475
Drug: Placebo
 Phase 2

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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in procedural pain intensity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative analgesic usage [ Designated as safety issue: No ]
  • Weekly Patient-rated Global Impression of Change [ Designated as safety issue: No ]
  • Additional quality of life assessments [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053702

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

No publications provided

Responsible Party: Medical Director, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01053702     History of Changes
Other Study ID Numbers: R475-PN-0909
Study First Received: January 19, 2010
Last Updated: April 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013