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

Purdue Pharma

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Hydromorphone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465647

HMP4009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 28 days to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 4 patient groups

≥ 28 Days to < 13 Months

Experimental group

Description:

infant and toddler

Treatment:

Drug: Hydromorphone

≥ 13 months to < 5 years

Experimental group

Description:

young child

Treatment:

Drug: Hydromorphone

≥ 5 years to < 12 years

Experimental group

Description:

older child

Treatment:

Drug: Hydromorphone

≥ 12 years to < 17 years

Experimental group

Description:

adolescent

Treatment:

Drug: Hydromorphone