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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

Page last updated: August 23, 2015

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