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

This study is not yet open for participant recruitment.

Verified by Endo Pharmaceuticals, December 2008

Sponsored by:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00801398

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 III

Drug Information available for: Oxymorphone Oxymorphone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	48
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxymorphone IR: Experimental 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

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

Contacts

Contact: Virginia Marinelli

marinelli.virginia@endo.com

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States
United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

Study Director:

Harry Ahdieh, Ph.D.

Endo Pharmaceuticals

More Information

Responsible Party:	Endo Pharmaceuticals Inc. ( Sr. Director, CR&D )
Study ID Numbers:	EN3203-010
Study First Received:	December 2, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00801398
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

Opioid tolerant
Pediatric
Pain
Non malignant
Malignant

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative
Oxymorphone

Additional relevant MeSH terms:

Adjuvants, Anesthesia
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009