Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects

NCT ID: NCT01322360

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-04-30

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Morphine Sulfate

Intervention Type: DRUG

Interventions

Morphine Sulfate

Intervention Type: DRUG

Other Intervention Names

Morphine Sulfate Oral Solution; Morphine Sulfate Tablet

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roxane Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dante Landucci, M.D.

Role: STUDY_DIRECTOR

Quintiles, Inc.

Locations

Maricopa Integrated Health System

Phoenix, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Stanford University Medical Center

Stanford, California, United States

Yale New Haven Children's Hospital

New Haven, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital

Akron, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health Science Center of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

MORP-OS+T-(2-17)-SPK-1

Identifier Type: -

Identifier Source: org_study_id