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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00801398
First received: December 2, 2008
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: Oxymorphone IR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801398

Locations
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
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00801398     History of Changes
Other Study ID Numbers: EN3203-010
Study First Received: December 2, 2008
Last Updated: October 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Opioid tolerant
Pediatric
Pain
Non malignant
Malignant

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Oxymorphone
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014