A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

Study identification

• EU PAS number:
  EUPAS11647
• Study ID:
  11648
• Official title and acronym:
  A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Multicenter, randomized, double-blinded, controlled study in pediatric dental patients 2 to 5 years of age undergoing Mandibular and Maxillary Procedures, whose objective was to determine the safety and tolerability of OraVerse.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novocol Pharmaceutical of Canada

Nationwide Children's Hospital Columbus, OH, Indiana University School of Dentistry Indianapolis, IN, University of Pennsylvania School of Dental Medicine Philadelphia, PA, University of California School of Dentistry San Francisco, CA, Jean Brown research Salt Lake City, UT, University of Pittsburgh Pittsburgh, PA

Study timelines

Date when funding contract was signed

Actual: 01/08/2011

Study start date

Actual: 14/02/2012

Date of final study report

Actual: 22/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novocol Pharmaceutical of Canada, Inc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable