Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01322360
First received: March 21, 2011
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Morphine Sulfate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
    Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade


Enrollment: 50
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine Sulfate
oral 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
Drug: Morphine Sulfate
Other Names:
  • Morphine Sulfate Oral Solution
  • Morphine Sulfate Tablet

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322360

Locations
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital
Akron, Ohio, United States, 44302
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
University of Texas Health Science Center of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Roxane Laboratories
Investigators
Study Director: Dante Landucci, M.D. Quintiles
  More Information

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01322360     History of Changes
Other Study ID Numbers: MORP-OS+T-(2-17)-SPK-1
Study First Received: March 21, 2011
Results First Received: July 16, 2013
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014