Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
A Multicenter, Open Label, Safety and Pharmacokinetic Study of Oral Morphine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Postoperative Pain
1 other identifier
interventional
50
1 country
11
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration. To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects. To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Apr 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
May 23, 2014
CompletedFebruary 5, 2018
January 1, 2018
1 year
March 21, 2011
July 16, 2013
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation
The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade. Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator.
Up to 21 days
Secondary Outcomes (1)
Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade
Up to 21 days
Study Arms (1)
Morphine Sulfate
OTHERoral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines
Interventions
Eligibility Criteria
You may qualify if:
- parent or guardian provided written parental permission/informed consent, with subject assent (if required by local IRB).
- The child is 2 years old through 17 years old, inclusive (at the time of informed consent signing).
- A routine pediatric procedure is expected to require inpatient hospitalization postoperatively.
- Must be an inpatient for the study treatment period.
- Is expected by the investigator to require use of oral opioid for the treatment of postoperative pain.
- Has the ability to read and understand the study procedures and has the ability to communicate meaningfully with the study investigator and staff (if the subject is of preverbal age or cannot read or communicate meaningfully, then the subject's parent or guardian must meet this criterion).
- Child is expected to experience moderate to severe postoperative pain, in the investigator's opinion, during the immediate postoperative period after discontinuation of intermittent administration of IV opioid (preferably morphine) and is able to tolerate oral medications.
- If female subject is of childbearing potential, she must have a negative pregnancy test result at screening (serum) and on the day of surgery prior to surgery (urine).
- Must have vascular access to facilitate blood draws.
You may not qualify if:
- Has used opioids chronically (e.g., codeine, morphine, oxycodone, or hydromorphone, for \>7 calendar days) within the previous 30 days.
- Has known hypersensitivity or contraindication to receiving oral opioid(s).
- Has a current active enteral malabsorption disorder.
- Has impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥3 times the upper limit of normal \[ULN\], or bilirubin ≥3 times ULN), known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral morphine exposure. Subjects with no previous history of liver function impairment may be enrolled prior to receipt of screening laboratory testing results.
- Has significantly impaired renal function or disease, as evidenced by an estimated glomerular filtration rate (i.e., from creatinine levels using the Schwartz formula) calculated to be less than one-third of normal for the applicable age of this study population. Subjects with no previous history of kidney function impairment may be enrolled prior to receipt of screening laboratory testing results.
- Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion.
- Has received epidural or regional anesthesia within 12 hours prior to the first dose of oral morphine sulfate.
- Has participated in an interventional clinical study (investigational or marketed product) within 30 days before screening, or plans to participate in another clinical trial in the next 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06510, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital
Akron, Ohio, 44302, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
University of Texas Health Science Center of Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anton (Tony) Amann, PhD, Executive Director, Drug Regulatory and Medical Affairs
- Organization
- Roxane Laboratories, Inc
Study Officials
- STUDY DIRECTOR
Dante Landucci, M.D.
Quintiles, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 24, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
February 5, 2018
Results First Posted
May 23, 2014
Record last verified: 2018-01