Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801398
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Oxymorphone IR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oxymorphone IR
Open-Label, 2 part ascending-dose multicenter study
Drug: Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Other Name: Opana IR

Primary Outcome Measures :
  1. 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. [ Time Frame: From baseline up to 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801398

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States, 20010
United States, Florida
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33607
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Endo Pharmaceuticals
Study Director: Study Director Endo Pharmaceuticals

Responsible Party: Endo Pharmaceuticals Identifier: NCT00801398     History of Changes
Other Study ID Numbers: EN3203-010
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Endo Pharmaceuticals:
Opioid tolerant
Non malignant

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia