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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
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Hydromorphone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Purdue Pharma LP

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

Summary

The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone 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 Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)

Secondary outcome:

Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]

Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time

Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time

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. Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition. The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.

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

- 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. Other protocol-specific inclusion/exclusion criteria may apply.

Locations and Contacts

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States

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

Stanford University Medical Center, Stanford, California 94305, United States

The Children's Hospital, Aurora, Colorado 80218, United States

Yale-New Haven Children's Hospital, New Haven, Connecticut 06510, United States

Jackson Memorial Hospital, Miami, Florida 33136, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

Saint Louis University - Department of Neurology and Psychiatry, St. Louis, Missouri 63104, United States

The University of North Carolina - CH, Chapel Hill, North Carolina 27599-7221, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States

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

Texas Children's Hospital / Baylor College of Medicine, Houston, Texas 77030, United States

The University of Texas, Health Sciences Center at Houston, Houston, Texas 77030, United States

Additional Information

Starting date: April 2007
Last updated: January 24, 2012

Page last updated: August 23, 2015

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