Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Information source: Endo Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Oxymorphone IR (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Endo Pharmaceuticals Official(s) and/or principal investigator(s):
Study Director, Study Director, Affiliation: Endo Pharmaceuticals
Overall contact:
Clinical Project Manager, Phone: 1-800-462-3636, Email: clinicaltrials@endo.com
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
Clinical Project Manager, Phone: 1-800-462-3636, Email: clinicaltrials@endo.com
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting
Email: clinicaltrials@endo.com
Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Email: clinicaltrials@endo.com
The Children's Hospital, Aurora, Colorado 80045, United States; Recruiting
Email: clinicaltrials@endo.com
Children's Research Institute, Washington, District of Columbia 20010, United States; Recruiting
Email: clinicaltrials@endo.com
St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33607, United States; Recruiting
Email: clinicaltrials@endo.com
Indiana University School of Medicine, Indianapolis, Indiana 46202, United States; Recruiting
Email: clinicaltrials@endo.com
Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Email: clinicaltrials@endo.com
The Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Email: clinicaltrials@endo.com
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee 37232, United States; Recruiting
Email: clinicaltrials@endo.com
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States; Recruiting
Email: clinicaltrials@endo.com
University of Washington, Seattle, Washington 98104, United States; Recruiting
Email: clinicaltrials@endo.com
Additional Information
Starting date: December 2008
Last updated: January 15, 2010
|
