Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:2 - 17
Updated:2/7/2018
Start Date:April 2011
End Date:April 2012

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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

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in
the investigator's judgment could compromise the subject's welfare, ability to
communicate with study staff, complete study activities, or would otherwise
contraindicate study participation. There is no minimum value for SpO2 for inclusion
in the study; this should be based on the investigator's judgment.

- 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.
We found this trial at
11
sites
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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2619 E. Pierce St.
Phoenix, Arizona 85008
602-344-5951
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Akron, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Nashville, TN
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New Haven, Connecticut 06511
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New Haven, CT
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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