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An Open-Label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

Information source: Purdue Pharma LP
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pain

Intervention: Hydromorphone HCl (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Purdue Pharma LP

Official(s) and/or principal investigator(s):
Gregory B. Hammer, MD, Principal Investigator, Affiliation: Stanford University

Overall contact:
Monica Leipold, Phone: 1-800-745-7445, Ext: 7449, Email: monica.leipold@pharma.com

Summary

The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone HCl oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone HCl oral solution in pediatric subjects aged 28 days to 16 years inclusive.

Clinical Details

Official title: A Multi-Center, Open-Label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone HCl Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: Concentrations of serum hydromorphone: immediately predose and 0.25 - 0.75, 1-3, and 4 - 6 hours postdose, for the first 2 doses immediately predose thereafter and end of study.

Secondary outcome: Pain scores based on: Numerical pain scale 10 cm VAS, Wong-Baker Faces Pain Scale, FLACC, supplemental analgesic requirements, adverse events, vital signs, respiratory rates, hemoglobin-oxygen saturation, and somnolence

Detailed description: Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects.

Eligibility

Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pediatric subjects aged 28 days to 16 years,

- Prospective subjects anticipated to have postoperative pain requiring oral opioid

analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),

- Prospective subjects have received no more than a total of 7 doses of opioids in the

30 days prior to surgery.

Exclusion Criteria:

- Prospective subjects with clinically significant hepatic or renal dysfunction and

impaired cardiac and/or respiratory reserve,

- Prospective subjects who have received opioid analgesic therapy other than

hydromorphone HCl or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone HCl,

- Prospective subjects who have received regional anesthetic blockade OR analgesic

treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone HCl.

Other protocol-specific inclusion/exclusion criteria may apply.

Locations and Contacts

Monica Leipold, Phone: 1-800-745-7445, Ext: 7449, Email: monica.leipold@pharma.com

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting
Michael L. Schmitz, MD
Michael L. Schmitz, MD, Principal Investigator

Stanford University Medical Center, Stanford, California 94305, United States; Recruiting
Gregory B Hammer, M.D., Phone: 650-723-7835

Children's Hospital of Orange County - Pediatric Subspecialty, Orange, California 92868, United States; Terminated

The Children's Hospital, Aurora, Colorado 80218, United States; Recruiting
Jeffrey Galinkin, MD
Jeffrey Galinkin, MD, Principal Investigator

Yale-New Haven Children's Hospital, New Haven, Connecticut 06510, United States; Recruiting
Brenda McClain, MD
Brenda McClain, MD, Principal Investigator

Jackson Memorial Hospital, Miami, Florida 33136, United States; Recruiting
Ralf E. Gebhard, MD
Ralf E. Gebhard, MD, Principal Investigator

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Thomas Loew, MD
Thomas Loew, MD, Principal Investigator

Saint Louis University - Department of Neurology and Psychiatry, St. Louis, Missouri 63104, United States; Recruiting
Thomas Geller, MD
Thomas Geller, MD, Principal Investigator

The University of North Carolina - CH, Chapel Hill, North Carolina 27599-7221, United States; Recruiting
Bradford D. Harris, MD
Bradford D. Harris, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Scott Schulman, MS
Scott Schulman, MD, Principal Investigator

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States; Recruiting
David Andrews, MD
David Andrews, MD, Principal Investigator

Texas Children's Hospital / Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Chris Glover, MD
Chris Glover, MD, Principal Investigator

Children's Medical Center, Dallas, Texas 75235, United States; Terminated

The University of Texas, Health Sciences Center at Houston, Houston, Texas 77030, United States; Recruiting
Samia Khalil, MD
Samia Khalil, MD, Principal Investigator

Additional Information

Starting date: April 2007
Ending date: April 2010
Last updated: February 5, 2009

Page last updated: February 12, 2009

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