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

NCT ID: NCT00465647

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-04-30

Brief 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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

≥ 28 Days to < 13 Months

infant and toddler

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.

≥ 13 months to < 5 years

young child

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.

≥ 5 years to < 12 years

older child

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.

≥ 12 years to < 17 years

adolescent

Group Type: EXPERIMENTAL

Hydromorphone

Intervention Type: DRUG

Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.

Interventions

Hydromorphone

Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.

Intervention Type: DRUG

Other Intervention Names

Infants and todlers; Young child; Older child; Adolescent.

Eligibility 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.

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory B. Hammer, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital of Orange County - Pediatric Subspecialty

Orange, California, United States

Stanford University Medical Center

Stanford, California, United States

The Children's Hospital

Aurora, Colorado, United States

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States

Jackson Memorial Hospital

Miami, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Saint Louis University - Department of Neurology and Psychiatry

St Louis, Missouri, United States

The University of North Carolina - CH

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Children's Medical Center

Dallas, Texas, United States

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas, United States

The University of Texas, Health Sciences Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HMP4009

Identifier Type: -

Identifier Source: org_study_id