Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Oxymorphone IR (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Endo Pharmaceuticals Official(s) and/or principal investigator(s): Study Director, Study Director, Affiliation: Endo Pharmaceuticals
Summary
When post-operative parenteral analgesia is discontinued, oral dosing with study medication
may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
(pain intensity score greater than or equal to 40).
Clinical Details
Official title: An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: During the Single-Dose Period, the safety of oxymorphone IR in children >12-17 years requiring an opioid to treat their acute postoperative pain of various etiologies will be assessed.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female > 12 to 17 years of age, inclusive
- Weigh at least 50 kg
- Postoperative oral opioid analgesia required for at least 24 hours or 48 hours
following postoperataive parenteral analgesia
- Are expected to be hospitalized for the duration of the study
Exclusion Criteria:
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy of < 4 weeks
- Positive pregnancy test at screening
Locations and Contacts
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States
Stanford University School of Medicine, Stanford, California 94305, United States
The Children's Hospital, Aurora, Colorado 80045, United States
Children's Research Institute, Washington, District of Columbia 20010, United States
St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33607, United States
Indiana University School of Medicine, Indianapolis, Indiana 46202, United States
Hershey Medical Center, Hershey, Pennsylvania 17033, United States
The Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee 37232, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States
University of Washington, Seattle, Washington 98104, United States
Additional Information
Starting date: December 2008
Last updated: June 10, 2015
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