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

NCT00465647 | Completed Phase 4 Results DMC

• 1 other identifier: HMP4009
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 14

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Hydromorphone oral solution; opioid; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

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

  Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only.

  A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.

Secondary Outcomes (3)

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

  Immediately prior to first oral dose, up to 54 hours

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

  Immediately prior to first oral dose with potentially up to 54 hours duration.

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

  Immediately prior to first oral dose, up to 54 hours

Study Arms (4)

≥ 28 Days to < 13 Months

EXPERIMENTAL

infant and toddler

Drug: Hydromorphone

≥ 13 months to < 5 years

EXPERIMENTAL

young child

Drug: Hydromorphone

≥ 5 years to < 12 years

EXPERIMENTAL

older child

Drug: Hydromorphone

≥ 12 years to < 17 years

EXPERIMENTAL

adolescent

Drug: Hydromorphone

Interventions

Hydromorphone 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.

Also known as: Infants and todlers;, Young child;, Older child;, Adolescent.

≥ 12 years to < 17 years; ≥ 13 months to < 5 years; ≥ 28 Days to < 13 Months; ≥ 5 years to < 12 years

Eligibility Criteria

• Age: 28 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (14)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital of Orange County - Pediatric Subspecialty

Orange, California, 92868, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

The Children's Hospital

Aurora, Colorado, 80218, United States

Location

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06510, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Saint Louis University - Department of Neurology and Psychiatry

St Louis, Missouri, 63104, United States

Location

The University of North Carolina - CH

Chapel Hill, North Carolina, 27599-7221, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital / Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The University of Texas, Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Executive Medical Director
• Organization: Purdue Pharma L.P.

800-733-1333

Study Officials

• Gregory B. Hammer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 25, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 18, 2015
• Results First Posted: March 11, 2011

Record last verified: 2015-10

Locations

US (14)